(144 days)
Not Found
No
The description focuses on the laser technology and its mechanical/optical function. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
Yes
A therapeutic device is used to treat a disease or condition. The DABRA Laser System's intended use is to cross chronic total occlusions in patients with vascular disease, which is a treatment for that condition. Additionally, the device description states that "The laser energy photoablates the lesion creating a lumen that permits blood flow," directly describing a therapeutic action.
No
The device description clearly states that the DABRA Laser System is used to "photoablates the lesion creating a lumen that permits blood flow" and "target the laser energy to the lesion," indicating a therapeutic rather than diagnostic function. Its intended use is for "crossing chronic total occlusions," which is an interventional treatment.
No
The device description clearly outlines hardware components including a laser light source, catheter, optical fiber, and lens, in addition to software control.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- DABRA Laser System Function: The provided description clearly states that the DABRA Laser System is used directly on the patient's vasculature to photoablate lesions and create a lumen. It is an interventional device used in vivo (within the living body).
- No Specimen Analysis: There is no mention of the device collecting or analyzing any specimens from the patient.
The DABRA Laser System is a therapeutic device used for a medical procedure performed directly on the patient.
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
The Ra Medical Systems' DABRA™ Laser Catheter model 101 and RA-308 Excimer Laser is composed of an Excimer laser light source and gamma sterilized single use catheter consisting of an extruded fluorinated ethylene propylene (FEP) tube coated on the inner diameter with an amorphous fluoropolymer thin film resulting in total internal reflection of 308 nm light capped at each end by optical fiber (fused silica).
The laser light is generated by a software-controlled 308nm Excimer source though a discharge excitation process within a gas filled resonating cavity. The light is directed to the catheter through a lens. The fiber and the fluid use total internal reflection to direct the ultraviolet laser energy from the laser light source to the tip of the catheter. The catheter is connected to the laser for the procedure, and then inserted into the patient's vasculature along the length of a previously inserted guide catheter, support catheter, quiding sheath, or introducer sheath allowing the physician to target the laser energy to the lesion.
The laser energy photoablates the lesion creating a lumen that permits blood flow. The lumen can be used for other interventional treatment devices. The system is designed to be used in a catheterization laboratory. This setting includes fluoroscopy devices, injecting devices, patient monitoring devices, a table for the patient, and personnel to assist the physician in performing the treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
infrainguinal lower extremity vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician in a catheterization laboratory
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)
The following performance data were provided in support of the substantial equivalence determination:
- Package integrity testing.
- Catheter performance testing.
- Calibration sleeve verification testing.
- Safety testing.
- Biocompatibility.
- Software testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" on the first line, "U.S. FOOD & DRUG" on the second line, and "ADMINISTRATION" on the third line.
July 27, 2021
Ra Medical Systems, Inc. Jami Miller Director Regulatory Affairs 2070 Las Palmas Drive Carlsbad, California 92011
Re: K210664
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: June 28, 2021 Received: June 29, 2021
Dear Jami Miller:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210664
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY
l Submitter Information
Ra Medical Systems. Inc. 2070 Las Palmas Drive, Carlsbad CA 92011 Company Phone: (760) 804 1648 Fax: (760) 804 1657 Contact: Jami Miller, Director Regulatory Affairs Date Prepared: February 19, 2021
. Device Identification
Device Trade Name: DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) Common Name: Laser Catheter, Excimer Laser Classification Name: Percutaneous catheter Regulatory Class: Class II (per 870.1250 percutaneous catheter) Device Code: PDU
III Identification of Predicate Device
DABRA Laser System (K170349)
IV Device Description
The Ra Medical Systems' DABRA™ Laser Catheter model 101 and RA-308 Excimer Laser is composed of an Excimer laser light source and gamma sterilized single use catheter consisting of an extruded fluorinated ethylene propylene (FEP) tube coated on the inner diameter with an amorphous fluoropolymer thin film resulting in total internal reflection of 308 nm light capped at each end by optical fiber (fused silica).
The laser light is generated by a software-controlled 308nm Excimer source though a discharge excitation process within a gas filled resonating cavity. The light is directed to the catheter through a lens. The fiber and the fluid use total internal reflection to direct the ultraviolet laser energy from the laser light source to the tip of the catheter. The catheter is connected to the laser for the procedure, and then inserted into the patient's vasculature along the length of a previously inserted guide catheter, support catheter, quiding sheath, or introducer sheath allowing the physician to target the laser energy to the lesion.
The laser energy photoablates the lesion creating a lumen that permits blood flow. The lumen can be used for other interventional treatment devices. The system is
4
designed to be used in a catheterization laboratory. This setting includes fluoroscopy devices, injecting devices, patient monitoring devices, a table for the patient, and personnel to assist the physician in performing the treatment.
V Intended Use (807.92(a)(5))
For use in ablating a channel in occlusive peripheral vascular disease.
Indications for Use
The DABRA Laser System is indicated for crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.
VI Technological Comparison to Predicate Device
The technological characteristics of the subject device is identical to the predicate device in its design, intended use, indications for use, target population, environments for use, fundamental scientific technology, principal of operation and method of action, packaging configuration, sterility assurance level (SAL) and method of sterilization.
The subject device is a modification to the predicate device and is different as follows:
- Changed calibration sleeve design. ●
- Strain relief design. .
- Addition of marker band.
- . Packaging changes.
- . New footswitch.
- . New wheels, additional labeling.
- . Changes to cleaning processes.
- Reduced shelf life to 60 days.
5
VII Performance Data
The following performance data were provided in support of the substantial equivalence determination:
- . Package integrity testing.
- Catheter performance testing. ●
- Calibration sleeve verification testing.
- . Safety testing.
- Biocompatibility. ●
- . Software testing.
VIII Conclusions
The identified differences do not raise new or different concerns of safety or effectiveness relative to the predicate device. Performance testing has demonstrated that the subject device met the applicable design output requirements and demonstrate that the modified device and predicate device are substantially equivalent.