(124 days)
No
The description focuses on the laser technology and mechanical properties of the device, with no mention of AI or ML. Software is mentioned for controlling the laser, but not in a way that suggests AI/ML capabilities.
Yes
The device directly treats a medical condition (chronic total occlusions) by photoablating lesions to restore blood flow, which is a therapeutic action.
No
The device is described as an Excimer Laser System used for treating chronic total occlusions by photoablating lesions, which indicates a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is composed of a reusable Excimer laser light source and a single-use catheter, which are hardware components. Software is mentioned as controlling the laser, but it is part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease." This describes a therapeutic procedure performed directly on the patient's body to treat a condition.
- Device Description: The description details a laser system and catheter that are inserted into the patient's vasculature to photoablate lesions. This is an interventional, in-vivo procedure.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze samples (like blood, tissue, etc.) or to provide diagnostic information about a patient's condition. IVDs are used to diagnose diseases or conditions.
Therefore, the DABRA Excimer Laser System is a therapeutic device used for a medical procedure, not a diagnostic device used for in-vitro testing.
N/A
Intended Use / Indications for Use
The DABRA Excimer Laser System is indicated for crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.
Product codes
PDU
Device Description
The Ra Medical Systems' DABRA™ Laser Catheter Model 2.0 and RA-308 Excimer Laser is composed of a reusable Excimer laser light source and e-beam sterilized single use catheter.
The laser light is generated by a software-controlled 308nm Excimer source and directed to the catheter through a lens. The fiber and the fluid 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, 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:
- Length
- Outside Diameter
- Tensile Strength
- Torque Transmission
- Column Strength
- Kink Resistance
- Buckling Force
- Radiopacity
- Insertion/ Retraction Force
- Calibration Sleeve Strength
- Energy Transmission
- Calibration
- Heat Generation
- Corrosion
- Removal From Coil
- Bubble Leak Testing
- Pouch Peel Strength
- Software Testing
- Sterilization Validation
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
June 29, 2022
Ra Medical Systems, Inc. Jami Miller Director of Regulatory Affairs 2070 Las Palmas Drive Carlsbad, California 92011
Re: K220544
Trade/Device Name: DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: May 24, 2022 Received: May 26, 2022
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.
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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 medical devices and radiation-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.
for
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220544
Device Name
DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)
Indications for Use (Describe)
The DABRA Excimer 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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510(k) SUMMARY
I 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: June 28, 2022
ll Device Identification
Device Trade Name: DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) Common Name: Laser Catheter, Excimer Laser Classification Name: Percutaneous catheter Requlatory Class: Class II (per 870.1250 percutaneous catheter) Device Code: PDU
III Identification of Predicate Device
DABRA Laser System (DABRA Laser Model RA-308 And DABRA Catheter Model 101) (K210664)
Reference Device: CLIRPATH Excimer Laser Catheter (K040067)
IV Device Description
The Ra Medical Systems' DABRA™ Laser Catheter Model 2.0 and RA-308 Excimer Laser is composed of a reusable Excimer laser light source and e-beam sterilized single use catheter.
The laser light is generated by a software-controlled 308nm Excimer source and directed to the catheter through a lens. The fiber and the fluid 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, 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.
4
V Intended Use (807.92(a)(5))
For use in ablating a channel in occlusive peripheral vascular disease.
Indications for Use
The DABRA Excimer 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 are 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, sterility assurance level (SAL).
| | Predicate Device
K210664
(DABRA 101) | Subject Device
(DABRA 2.0) |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Intended use | For use in ablating a channel in
totally occlusive peripheral
vascular disease. | Identical |
| Indications for use | The DABRA Laser System is
indicated for crossing chronic
total occlusions in patients with
symptomatic infrainguinal lower
extremity vascular disease. | Identical |
| Target Population | Patients with Peripheral Artery
Disease | Identical |
| Procedure Site | Catheterization Laboratory | Identical |
| Technology | 308 nm Excimer laser with
optical transmitting catheter to
lesion
Repetition rate 20 to 80 Hz
adjustable
Energy output 8 mJ minimum
Energy density (delivered)
across ablation area 7-15
mJ/mm²
Pulse width 15-120 ns | Identical |
| Principal of Operation
/Mechanism of action | Photoablation | Identical |
5
| Catheter provided
| sterile | Yes | Identical |
|---|---|---|
| Sterility Assurance | ||
| Level of Catheter | 10-6 | Identical |
| Single Use Catheter | Yes | Identical |
| Tip Diameter(s) | 1.5 mm | Identical |
| Working length | 150 cm | Identical |
The subject device is a modification to the predicate device with the following differences:
| Technological
Characteristic | Predicate Device
K210664
(DABRA 101) | Subject Device
(DABRA 2.0) |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Catheter outer jacket | Pebax with polyamide outer
jackets | Pebax with stainless steel braid
over polyimide/PTFE liner |
| Length, overall | 200 cm | 210 cm |
| Calibration sleeve
adhesive | Solvent bond | Cyanoacrylate |
| Optical fluid | H2O | Dilute saline |
| Distal tip and glass
length | Tip Length 0.180
Glass Length 7mm | Tip Length 0.139"
Glass Length 5mm |
| Location of marker
band | Inside distal tip | Behind distal tip |
| Strain relief design | Santoprene, 2.1" | Pebax, 4.35" |
| Sterilization | Gamma irradiation | Electron beam irradiation. Both
methods provide a product
sterilized to 10-6 SAL. |
| Packaging Design | Proximal end of catheter held in
coil with tab on coil card, circular
spiral coil, non-barbed plug.
Shipper Box contains 12 shelf
boxes. | Catheter holder seals the
catheter to the packaging coil.
Coil is larger in ID and has a
larger bend radius. Oblong
"racetrack". Added barbed
elbow connector to seal larger
coil.
Larger shelf box and shipper
box. Shipper box contains 8
shelf boxes. |
| Packaging Materials | Pouch - Mylar | Breathable Tyvek material,
larger pouch. |
| Shelf life | 60 Days | 6 Months |
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| Software | No warm-up at the beginning of the calibration cycle | Added 15 second warm-up at the beginning of the calibration cycle |
|---|---|---|
| ---------- | ------------------------------------------------------ | ------------------------------------------------------------------- |
VII Performance Data
The following performance data were provided in support of the substantial equivalence determination:
- Length
- Outside Diameter
- Tensile Strength
- · Torque Transmission
- Column Strength
- Kink Resistance
- Buckling Force
- · Radiopacity
- Insertion/ Retraction Force
- · Calibration Sleeve Strength
- · Energy Transmission
- Calibration
- · Heat Generation
- Corrosion
- Removal From Coil
- Bubble Leak Testing
- Pouch Peel Strength
- · Software Testing
- Sterilization Validation
Biocompatibility testing
The DABRA 2.0 catheter was subjected to, and passed, the following biocompatibility testing:
- Cytotoxicity
- ISO Guinea Pig Maximization Sensitization Test ●
- ISO Intracutaneous Study in Rabbits ●
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- Acute Systemic Toxicity .
- Material Mediated Pyrogenicity in Rabbits ●
- Hemocompatibility: ASTM Hemolysis (Direct and Indirect) ●
- Hemocompatibility: ASTM Partial Thromboplastin Time ●
- Hemocompatibility: SC5b-9 Complement Activation Assay .
- Hemocompatibility: In Vivo Thromboresistance .
Conclusions VIII
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 will perform as well as or better than the predicate device. The device has met the applicable design output requirements, demonstrating that the modified device and predicate device are substantially equivalent.