(110 days)
No
The device description focuses on the physical components and the mechanism of action (photoablation) using a laser. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is described as treating chronic total occlusions to permit blood flow and alleviate symptoms in patients with symptomatic infrainguinal lower extremity vascular disease, which directly addresses a medical condition.
No
The device description clearly states its purpose is to photoablate lesion material to create a lumen for blood flow, allowing access for other interventional treatment devices. This is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines hardware components including a laser light source, catheter, tubing, optical windows, and patient-contacting parts made of titanium, glass, epoxy, and FEP. This is a physical medical device that utilizes laser technology.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- DABRA Laser System Function: The DABRA Laser System is a therapeutic device that uses laser energy to physically ablate (remove) blockages in blood vessels. It is inserted directly into the patient's body and interacts with the tissue in vivo (within the living organism).
- Lack of Sample Analysis: The description does not mention the device analyzing any samples taken from the patient. Its function is to directly treat a condition within the body.
Therefore, the DABRA Laser System falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DABRA Laser System is indicated for crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.
Product codes (comma separated list FDA assigned to the subject device)
PDU
Device Description
Ra Medical Systems is requesting FDA 510(k) clearance for the DABRA Laser (model RA-308) and DABRATM Catheter (model 101) as a system, collectively the DABRA Laser System™.
The Ra Medical Systems' DABRA Laser System™ is composed of a laser light source and catheter consisting of optically conducting fluid encased in medical grade tubing enclosed by an optical window on either end. The tip and the fluid conduct the ultraviolet laser energy from the laser light source to the distal tip of the catheter. The laser light is generated by a 308nm excimer source. The catheter is connected to the laser for the procedure, and then inserted into the patient's vasculature, allowing the physician to target the laser energy to a blockage or lesion. Patient contacting parts of the device are the distal tip (titanium), the distal tip window (glass), the glue for the distal tip (epoxy), and the catheter tube (FEP). These parts are limited (
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
Public Health Service
Image /page/0/Picture/2 description: The image is a circular seal for the U.S. Department of Health & Human Services. The seal features the department's emblem, which consists of a stylized caduceus with three intertwined snakes and a staff. The emblem is positioned in the center of the seal. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper perimeter of the circle.
May 24, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Ra Medical Systems, Inc. Mr. Dean Irwin CEO 1930 Kellogg Ave. Carlsbad. CA 92008
Re: K170349
Trade/Device Name: DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: April 24, 2017 Received: April 24, 2017
Dear Mr. Irwin:
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 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Fernando
Aguel-S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170349
Device Name
DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)
Indications for Use (Describe)
The DABRA Laser System is indicated for crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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PREMARKET NOTIFICATION
TRADITIONAL 510(k) SUMMARY
Submitter Information
A. Company Name: Ra Medical Systems, Inc.
- B. Company address: 1930 Kellogg Ave, Carlsbad CA 92008
- C. Company Phone: (760) 804 1648 / (877) 635 1800 Fax: (760) 804 1657
- D. Contact Person: Dean Irwin, Chief Executive Officer
- E. Date Prepared: January 20, 2017
Device Identification
- A. Device Trade Name: DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101)
- B. Device Common Name: Laser Catheter, Excimer Laser
- C. Classification Name: Percutaneous catheter
- D. Device Class: Class II (per 870.1250 percutaneous catheter)
E. Device Code: PDU
Identification of Predicate Device
Spectranetics CLiRpath Laser Catheters; K040067.
Identification of Reference Devices
Ra Medical EX-308; K062963
Spectranetics CVX-300; K052514
Device Description
Ra Medical Systems is requesting FDA 510(k) clearance for the DABRA Laser (model RA-308) and DABRATM Catheter (model 101) as a system, collectively the DABRA Laser System™.
The Ra Medical Systems' DABRA Laser System™ is composed of a laser light source and catheter consisting of optically conducting fluid encased in medical grade tubing enclosed by an optical window on either end. The tip and the fluid conduct the ultraviolet laser energy from the laser light source to the distal tip of the catheter. The laser light is generated by a 308nm excimer source. The catheter is connected to the laser for the procedure, and then inserted into the patient's vasculature, allowing the physician to target the laser energy to a blockage or lesion. Patient contacting parts of the device are the distal tip (titanium), the distal tip window (glass), the glue for the distal tip (epoxy), and the catheter tube (FEP). These parts are limited (