The DABRA Excimer Laser System is indicated for crossing chronic total occlusions in patients with symptomatic infrainguinal lower extremity vascular disease.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0). The primary purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove the device meets specific acceptance criteria related to AI/ML model performance for diagnostic tasks.

The document focuses on the mechanical, material, and functional characteristics of a medical device (a laser and catheter system) and its substantial equivalence to a previously cleared device. It is not about an AI/ML diagnostic device. Therefore, most of the requested information regarding AI/ML model acceptance criteria, ground truth establishment, expert adjudication, MRMC studies, and standalone performance is not applicable to this document, as it does not describe an AI/ML system.

However, I can extract the "performance data" provided in support of substantial equivalence, which can be interpreted as the studies done to prove the device meets certain functional and safety criteria, even if these are not "acceptance criteria" in the context of an AI/ML model's diagnostic accuracy.

Here's a breakdown of what can be extracted or inferred based on the provided text, and what is explicitly not applicable:

"Acceptance Criteria" (interpreted as Performance Data for a Laser/Catheter System):

The document lists "Performance Data" which are essentially the tests conducted to demonstrate the device's functionality and safety. These are not acceptance criteria in the sense of a diagnostic accuracy threshold for an AI model, but rather engineering and biocompatibility evaluations. The document states that the device "passed" these tests and "met the applicable design output requirements."

Table of Acceptance Criteria and Reported Device Performance (as far as discernible for a non-AI device):

Acceptance Criterion (Type of Test)	Reported Device Performance / Conclusion
Length	Passed
Outside Diameter	Passed
Tensile Strength	Passed
Torque Transmission	Passed
Column Strength	Passed
Kink Resistance	Passed
Buckling Force	Passed
Radiopacity	Passed
Insertion/Retraction Force	Passed
Calibration Sleeve Strength	Passed
Energy Transmission	Passed
Calibration	Passed
Heat Generation	Passed
Corrosion	Passed
Removal From Coil	Passed
Bubble Leak Testing	Passed
Pouch Peel Strength	Passed
Software Testing	Passed
Sterilization Validation	Passed
Biocompatibility: Cytotoxicity	Passed
Biocompatibility: ISO Guinea Pig Maximization Sensitization Test	Passed
Biocompatibility: ISO Intracutaneous Study in Rabbits	Passed
Biocompatibility: Acute Systemic Toxicity	Passed
Biocompatibility: Material Mediated Pyrogenicity in Rabbits	Passed
Biocompatibility: Hemocompatibility (ASTM Hemolysis - Direct and Indirect)	Passed
Biocompatibility: Hemocompatibility (ASTM Partial Thromboplastin Time)	Passed
Biocompatibility: Hemocompatibility (SC5b-9 Complement Activation Assay)	Passed
Biocompatibility: Hemocompatibility (In Vivo Thromboresistance)	Passed

Regarding the specific questions about AI/ML device validation:

A table of acceptance criteria and the reported device performance: See table above, reinterpreted as engineering/safety tests for this type of device. Specific quantitative thresholds for "Pass" are not provided in this summary document.
Sample sized used for the test set and the data provenance: Not applicable. This is not an AI/ML diagnostic device. The "test set" would refer to the number of units/samples tested for the physical and biological performance data. This information (e.g., how many catheters were tested for tensile strength) is not provided in this summary. The data provenance is for a medical device (laser and catheter) and would typically be internal lab testing by the manufacturer.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the diagnostic sense is established for this type of device. Engineering and biocompatibility testing rely on established standards and methods.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This product is a physical device (laser and catheter), not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of diagnostic "ground truth." The "ground truth" for the performance claims would be the adherence to validated engineering specifications and biocompatibility standards.
The sample size for the training set: Not applicable. This is a physical device, not an AI model.
How the ground truth for the training set was established: Not applicable.

Summary Conclusion:

The provided document, K220544, pertains to a physical medical device (laser and catheter system), not an AI/ML diagnostic or assistive device. Therefore, the questions related to AI/ML model validation (e.g., ground truth, experts, MRMC studies, training/test sets for algorithms) are not relevant to the information contained within this 510(k) summary. The "performance data" listed are standard engineering and biocompatibility tests to demonstrate the device's functional and safety characteristics and its substantial equivalence to a predicate device.

Summary

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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.

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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 DeviceK210664(DABRA 101)	Subject Device(DABRA 2.0)
Intended use	For use in ablating a channel intotally occlusive peripheralvascular disease.	Identical
Indications for use	The DABRA Laser System isindicated for crossing chronictotal occlusions in patients withsymptomatic infrainguinal lowerextremity vascular disease.	Identical
Target Population	Patients with Peripheral ArteryDisease	Identical
Procedure Site	Catheterization Laboratory	Identical
Technology	308 nm Excimer laser withoptical transmitting catheter tolesionRepetition rate 20 to 80 HzadjustableEnergy output 8 mJ minimumEnergy density (delivered)across ablation area 7-15mJ/mm²Pulse width 15-120 ns	Identical
Principal of Operation/Mechanism of action	Photoablation	Identical

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Catheter providedsterile	Yes	Identical
Sterility AssuranceLevel 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:

TechnologicalCharacteristic	Predicate DeviceK210664(DABRA 101)	Subject Device(DABRA 2.0)
Catheter outer jacket	Pebax with polyamide outerjackets	Pebax with stainless steel braidover polyimide/PTFE liner
Length, overall	200 cm	210 cm
Calibration sleeveadhesive	Solvent bond	Cyanoacrylate
Optical fluid	H2O	Dilute saline
Distal tip and glasslength	Tip Length 0.180Glass Length 7mm	Tip Length 0.139"Glass Length 5mm
Location of markerband	Inside distal tip	Behind distal tip
Strain relief design	Santoprene, 2.1"	Pebax, 4.35"
Sterilization	Gamma irradiation	Electron beam irradiation. Bothmethods provide a productsterilized to 10-6 SAL.
Packaging Design	Proximal end of catheter held incoil with tab on coil card, circularspiral coil, non-barbed plug.Shipper Box contains 12 shelfboxes.	Catheter holder seals thecatheter to the packaging coil.Coil is larger in ID and has alarger bend radius. Oblong"racetrack". Added barbedelbow connector to seal largercoil.Larger shelf box and shipperbox. Shipper box contains 8shelf 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
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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.

Regulation Number and Section

§ 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).