DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)

K220544 · Ra Medical Systems,Inc · PDU · Jun 29, 2022 · Cardiovascular

Device Facts

• Record ID: K220544
• Device Name: DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0)
• Applicant: Ra Medical Systems,Inc
• Product Code: PDU · Cardiovascular
• Decision Date: Jun 29, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For use in ablating a channel in occlusive peripheral vascular disease.

Device Story

DABRA Excimer Laser System consists of reusable 308nm Excimer laser light source and single-use catheter. Physician operates system in catheterization laboratory; inserts catheter into patient vasculature. Laser energy delivered via fiber optics to catheter tip; photoablates lesion to create lumen for blood flow or subsequent interventional treatment. System includes fluoroscopy, injection, and monitoring equipment. Software controls laser source and calibration cycle. Benefits include recanalization of occluded vessels in symptomatic peripheral artery disease patients.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including mechanical properties (tensile strength, torque, kink resistance, buckling force), energy transmission, heat generation, and sterilization validation. Biocompatibility testing performed per ISO 10993 standards, including cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogenicity, and comprehensive hemocompatibility assays (hemolysis, PTT, complement activation, in vivo thromboresistance).

Technological Characteristics

308nm Excimer laser source; optical fiber delivery. Catheter materials: Pebax, stainless steel braid, polyimide/PTFE liner. Tip diameter 1.5mm; working length 150cm. Energy output 8mJ min; energy density 7-15mJ/mm²; pulse width 15-120ns. Repetition rate 20-80Hz. Sterilization: E-beam (10^-6 SAL). Software-controlled calibration. Connectivity: Standalone system for cath lab use.

Indications for Use

Indicated for crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.

Regulatory Classification

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.

Predicate Devices

• DABRA Laser System (DABRA Laser Model RA-308 And DABRA Catheter Model 101) (K210664)

Reference Devices

• CLIRPATH Excimer Laser Catheter (K040067)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: [phone] Fax: [phone] 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.

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# 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<br>K210664<br>(DABRA 101) | Subject Device<br>(DABRA 2.0) |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Intended use | For use in ablating a channel in<br>totally occlusive peripheral<br>vascular disease. | Identical |
| Indications for use | The DABRA Laser System is<br>indicated for crossing chronic<br>total occlusions in patients with<br>symptomatic infrainguinal lower<br>extremity vascular disease. | Identical |
| Target Population | Patients with Peripheral Artery<br>Disease | Identical |
| Procedure Site | Catheterization Laboratory | Identical |
| Technology | 308 nm Excimer laser with<br>optical transmitting catheter to<br>lesion<br>Repetition rate 20 to 80 Hz<br>adjustable<br>Energy output 8 mJ minimum<br>Energy density (delivered)<br>across ablation area 7-15<br>mJ/mm²<br>Pulse width 15-120 ns | Identical |
| Principal of Operation<br>/Mechanism of action | Photoablation | Identical |

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| Catheter provided<br>sterile | Yes | Identical |
|------------------------------------------|--------|-----------|
| Sterility Assurance<br>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<br>Characteristic | Predicate Device<br>K210664<br>(DABRA 101) | Subject Device<br>(DABRA 2.0) |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Catheter outer jacket | Pebax with polyamide outer<br>jackets | Pebax with stainless steel braid<br>over polyimide/PTFE liner |
| Length, overall | 200 cm | 210 cm |
| Calibration sleeve<br>adhesive | Solvent bond | Cyanoacrylate |
| Optical fluid | H2O | Dilute saline |
| Distal tip and glass<br>length | Tip Length 0.180<br>Glass Length 7mm | Tip Length 0.139"<br>Glass Length 5mm |
| Location of marker<br>band | Inside distal tip | Behind distal tip |
| Strain relief design | Santoprene, 2.1" | Pebax, 4.35" |
| Sterilization | Gamma irradiation | Electron beam irradiation. Both<br>methods provide a product<br>sterilized to 10-6 SAL. |
| Packaging Design | Proximal end of catheter held in<br>coil with tab on coil card, circular<br>spiral coil, non-barbed plug.<br>Shipper Box contains 12 shelf<br>boxes. | Catheter holder seals the<br>catheter to the packaging coil.<br>Coil is larger in ID and has a<br>larger bend radius. Oblong<br>"racetrack". Added barbed<br>elbow connector to seal larger<br>coil.<br>Larger shelf box and shipper<br>box. Shipper box contains 8<br>shelf boxes. |
| Packaging Materials | Pouch - Mylar | Breathable Tyvek material,<br>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.