(196 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 device is described as a modification of a laser, and its intended use is focused on surgical procedures using energy.
Yes
The device is used for cutting, vaporization, and coagulation of soft tissue in various medical specialties, which are all therapeutic procedures.
No
The Solvo is intended for cutting, vaporization, and coagulation of soft tissue, indicating a therapeutic function rather than a diagnostic one.
No
The device description explicitly states it is a modification to a laser device (Dornier's Medilas H20 Laser), which is a hardware medical device. The intended use also describes surgical procedures involving cutting, vaporization, and coagulation of soft tissue, which are physical actions performed by 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 the device as being used for cutting, vaporization, and coagulation of soft tissue during surgical procedures (endoscopic and open surgery). This is a direct intervention on the patient's body.
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, tissue samples) taken from the human body to provide information about a person's health status. They are used outside the body.
- Device Description: The description mentions it's a modification of a surgical laser, which aligns with the surgical intended use.
The Solvo is a surgical device used for therapeutic purposes, not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
The Solvo is intended to be used for cutting, vaporization, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coagulation of soft tissue. The Solvo is indicated for use in medicine and surgery, in the following medical specialties:
- Arthroscopy .
- Urology
- Lithotripsy
- Pulmonology
- Gastroenterology
- Gynecology
- ENT .
- General Surgery
Product codes
GEX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
Not Found
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
510(k) SUMMARY
Medilas H Solvo
FEB 0 1 2013
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Dornier MedTech America 1155 Roberts Blvd. Kennesaw, GA 30144
Phone: 770-514-6163 Fax: 770-514-6291 Date Prepared: 07/18/2012
Contact Person: John Hoffer
Phone: 770-514-6163
Name of Device and Name/Address of Sponsor
Medilas H Solvo 1155 Roberts Blvd. Kennesaw, GA 30144
Common or Usual Name
Holmium: Yttrium Aluminum Garnet (HO:YAG) Laser System
Classification Name
The General and Plastic Surgery Branch has classified Surgical Powered Laser Instruments (Product Code GEX) as a Class II device pursuant to 21 C.F.R. § 878.4810.
Predicate Devices
Dornier Medilas H20 Laser K061455
Purpose of the Special 510(k) Notice
The Solvo is a modification to Dornier's Medilas H20 Laser K061455.
Intended Use
The Solvo is intended to be used for cutting, vaporization, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, bysteroscopes, gastroscopes, cystoscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, ablation and coagulation of soft tissue. The Solvo is indicated for use in medicine and surgery, in the following medical specialties:
- Arthroscopy
- Urology
- Lithotripsy
- Pulmonology
- Gastroenterology
- Gynecology
- ENT
- General Surgery
1
Substantial Equivalence
From a clinical perspective and comparing design specifications, the Solvo and the predicate devices are substantially equivalent and have the same intended use. Based on the technological characteristics, design and overall performance of the devices, Dornier MedTech America believes that no significant differences exist between the Solvo and Dornier's Medilas H20 Laser (K061455).
Dornier MedTech America, Inc. believes the minor differences do not raise any concerns regarding the overall safety or effectiveness. Thus, the Solvo is substantially equivalent to its predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles an abstract caduceus, with three intertwined lines representing the branches of government or aspects of health and human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
FEB 0 1 2013
Dornier MedTech America, Inc. % John S. Hoffer, VP Quality, Regulatory, Clinical 1155 Roberts Boulevard, Suite 100 Kennesaw, Georgia 30144
Re: K122159
Trade/Device Name: Medilas H Solvo Holmium Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgicial instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: December 31, 2012 Received: January 03, 2013
Dear Mr. Hoffer:
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
3
Page 2 - John S. Hoffer, VP Quality, Regulatory, Clinical
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/ucm 1.15809.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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K122159
Device Name: Medilas H Solvo
Indications for Use:
The Solvo is intended to be used for cutting, vaporization, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coagulation of soft tissue. The Solvo is indicated for use in medicine and surgery, in the following medical specialties:
- Arthroscopy .
- Urology
- Lithotripsy
- Pulmonology
- Gastroenterology
- Gynecology
- ENT .
- General Surgery
Prescription Use _ X (Per 21 C.F.R. 801.109) AND/OR
Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R Ogden 2013.02.04 ,1 1:05:47 -05'00'
(Division Sign-Off)
Division of Surgical Devices
510(k) Number __K122159