Who is the manufacturer of SOLOPASS System?

Intravent Medical Partners, LP filed the 510(k) submission for SOLOPASS System (K203251).

What is the FDA product code for SOLOPASS System?

HAW. It is classified under 21 CFR 882.4560 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for SOLOPASS System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like SOLOPASS System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SOLOPASS System

K203251 · Intravent Medical Partners, LP · HAW · Aug 27, 2021 · Neurology

Device Facts

Record ID	K203251
Device Name	SOLOPASS System
Applicant	Intravent Medical Partners, LP
Product Code	HAW · Neurology
Decision Date	Aug 27, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4560
Device Class	Class 2

Intended Use

The SOLOPASS® System is a tool that obtains ultrasound images and positional data to provide intra-procedural, image guided localization and navigation, to aid in the frontal placement of an intra-ventricular catheter.

Device Story

SOLOPASS System is a neuronavigational tool for intra-ventricular catheter placement. It consists of a skull-mounted Patient Interface Device (PID), a cranial burr-hole ultrasound probe, and a portable workstation with a 27-inch monitor and foot pedal. The PID secures the probe and catheter guide while translating mechanical motion into digital position data. The system captures 2D ultrasound images and simultaneous location data to construct a 3D anatomical model. Surgeons or intensivists use the workstation interface to plan the catheter trajectory. Once the target is selected, the PID is locked to guide the catheter. Used in the OR or at the patient bedside, the system provides real-time image guidance to assist in accurate catheter placement, potentially reducing targeting risks. The device is manually operated by the clinician.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified via biocompatibility (ISO 10993), electrical/mechanical safety (IEC 60601 series), sterilization validation (VHP and Gamma), and simulated-use design validation. Targeting accuracy verified at +/- 3mm at 6cm depth; imaging accuracy verified at +/- 2mm at 4-7cm depth.

Technological Characteristics

System includes a skull-mounted mechanical PID, a 5 MHz phased array ultrasound probe, and a workstation. Materials conform to ISO 10993-1. PID is gamma-sterilized (single-use); probe is VHP-sterilized (reusable). Connectivity via workstation. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2. Mechanical testing of PID anchor per ASTM F543.

Indications for Use

Indicated for use as a tool to obtain ultrasound images and positional data for intra-procedural, image-guided localization and navigation to aid in the frontal placement of an intra-ventricular catheter in cranial neurosurgical procedures.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

Sonowand Invite System (K083597, K112469)

Reference Devices

Medtronic Navigus Trajectory Guide Kit (K992304)
V-Guide for Ventriculostomies (K141559)

Related Devices

K251317 — SOLOPASS 2.0 System · Intravent Medical Partners · Sep 5, 2025
K183325 — Modus Nav · Synaptive Medical, Inc. · Jul 14, 2019
K242480 — FLASH EVD System (10-0002) · 7D Surgical ULC · Dec 27, 2024
K141559 — V-GUIDE FOR VENTRICULOSTOMIES · Arc Surgical, LLC · Feb 27, 2015
K142024 — BRIGHTMATTER NAVIGATION SYSTEM · Synaptive Medical, Inc. · Apr 2, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. August 27, 2021 inTRAvent Medical Partners, LP % Connie Qiu Regulatory Consultant M Squared Associates, Inc. 127 West 30th Street. 9th Floor New York, New York 10001 ## Re: K203251 Trade/Device Name: SOLOPASS System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW, IYN Dated: December 3, 2020 Received: December 4, 2020 ## Dear Connie Qiu: 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. 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 {1}------------------------------------------------ 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, Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K203251 Device Name SOLOPASS® System Indications for Use (Describe) The SOLOPASS® System is a tool that obtains ultrasound images and positional data to provide intra-procedural, image guided localization and navigation, to aid in the frontal placement of an intra-ventricular catheter. 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 | Sponsor: | inTRAvent Medical Partners, LP 1125 Greenwood Dr. Hummelstown, PA 17036 | |-----------------|--------------------------------------------------------------------------------------------------------------------------------| | Contact: | Connie Qiu M Squared Associates, Inc. 127 West 30th Street, 9th Floor New York, NY 10001 | | Date Prepared: | August 27, 2021 | | Trade Name: | SOLOPASS® System | | Common Name: | Neurological stereotaxic instrument | | Classification: | II | | Product Code: | HAW, 21 CFR 882.4560, Neurological Stereotaxic Instrument IYN, 21 CFR 892.1550, System, Imaging, Pulsed Doppler, Ultrasonic | ### Predicate Devices: - Sonowand Invite System, K083597, K112469 ### Reference Devices - . Medtronic Navigus Trajectory Guide Kit, K992304 - V-Guide for Ventriculostomies K141559 ### Description of Device: The SOLOPASS® System is a neuronavigational system that collects intraoperative ultrasound imaging referenced to a skull mounted fixation device, allowing the user to plan the desired placement for external ventricular drain (EVD). The system utilizes two-dimensional imaging data with simultaneously captured location data to build a three-dimensional model of the anatomy. Once the user has chosen a catheter placement location, the fixation device is locked in place to guide a catheter towards the intended anatomic location. The SOLOPASS® System consists of three main sub-systems: - 1. The Patient Interface Device (PID): A skull-mounted fixation device that translates mechanical motion into digital position and secures the Ultrasound Probe and Catheter Guide. {4}------------------------------------------------ - 2. The Ultrasound Probe "The Probe": A custom cranial "burr-hole" style probe used to collect intraoperative ultrasound image data from the patient. - 3. The Workstation: A custom, portable unit that includes a dedicated operating system, imaging software application, and 27" monitor for displaying the User Interface. The Workstation is the primary interface of the other subsystems and is controlled by the included foot pedal. The SOLOPASS® System provides 2mm Imaging Accuracy at 4-7cm depth and 3mm Targeting Accuracy at 6cm depth. ## Indications for Use: The SOLOPASS® System is a tool that obtains ultrasound images and positional data to provide intra-procedural, image guided localization and navigation, to aid in the frontal placement of an intra-ventricular catheter. ## Comparison to Predicate Device: Comparison of intended use and technological characteristics between the SOLOPASS® System to the predicate device, Sonowand Invite System (K083597, K112469), is presented in the following table. The differences between the two devices do not affect the intended use, and do not raise new questions of safety and effectiveness. | | Subject Device | Predicate Device | Substantial Equivalence Comparison | |-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | SOLOPASS® System | SonoWand Invite™ K083597, K112469 | N/A | | Product Codes | HAW, IYN | HAW, IYN | Same | | Indications for Use | The SOLOPASS® System is a tool that obtains ultrasound images and positional data to provide intra- procedural, image guided localization and navigation, to aid in the frontal placement of an intra-ventricular catheter. | The SonoWand Invite™ System is intended for use as a tool to aid intraoperative ultrasound imaging and image guided surgery during neurosurgery. It is also intended for use as a standard neuronavigation system and as a stand-alone Ultrasound scanner. The intended use of a localizer is to enable | Same intended use are tools used to assist the surgeon in planning and guiding the placement of instruments during neurosurgical procedures, such as catheter placement, with image guidance provided by ultrasound or other imaging modality. Predicate device has additional indications regarding other imaging modalities. These differences do not raise | | | | navigation by showing the position of surgical instruments or pointers relative to MR, CT, or Ultrasound images. The general purpose localizers with adapters are intended to be used to attach surgical tools manufactured by other vendors. SonoWand Invite™ System will display position and orientation of the tools in the medical images on the screen. | new questions of safety or effectiveness. | | Planned Use Environment | Operating Room (OR), Patient Bedside outside of OR | Operating Room | Similar. Both devices are intended for use in the OR. The subject device is designed as a mobile workstation to allow for use at the patient bedside outside of the OR by qualified clinicians. While this adds a use environment, the intended use and qualifications of the intended users are equivalent to those of the predicate device. Electrical safety and electromagnetic compatibility testing using recognized test standards support the safety of the SOLOPASS as a mobile system. Therefore, these. | | | | | | | Planned User | Surgeon or intensivists | Surgeon | differences do not raise new questions of safety and effectiveness. Similar. Typically this procedure is performed by HCP such as a surgeon or intensivist. | | Anatomic region Use for neurosurgical catheter/ instrument placement | Cranial Yes | Cranial Yes | Same Same | | Main System Components | Ultrasound Imaging System; Skull mounted mechanical module; Software Module for trajectory planning; Workstation/ Display; Cart. | Ultrasound Imaging System; Not skull mounted (Localizer and Navigation Trackers on probe); Radiographic fiducial markers; Software module for instrument tracking; Workstation/ Display; Cart. | Similar. Both devices utilize an ultrasound imaging system with custom software module to aid in instrument (e.g. catheter) placement, and consist of a workstation with display on a cart. The subject device offers the benefit of intraoperative ultrasound images updated in real-time to facilitate trajectory planning and potentially reduce risks associated with targeting. There are differences in how each system helps track/guide placement of the instruments. Verification testing demonstrates that the subject device fulfills its design inputs including comparable accuracy to the predicate device. The differences between the main system components do not raise new questions of safety and effectiveness. | | | | | | | Image guidance | Ultrasound Intra-op 2D imaging data with simultaneously captured location data is used to build 3D model of anatomy | CT: Pre-op MRI: Pre-op Ultrasound: Intra-op (Intra-op MRI only available if MRI surgical suite available) Provides 2D and 3D imaging. | Both devices provide intra-op ultrasound imaging, and provide 2D and 3D imaging. The predicate device offers additional imaging modalities not offered by the subject device. This difference does not raise new questions of safety and effectiveness. | | Trajectory guide function | Yes | Yes | Same | | Patient fixation | Skull-mounted frame (Patient Interface Device, PID) serves as reference for instruments and catheters | No patient fixation component. Disposable radiographic markers are placed on or near craniotomy site. | Different. While the subject device includes a component that is fixed to the patient to guide placement of the ultrasound probe and instruments/ catheters, the predicate device does not have a patient fixation component. The two devices' designs utilize different methods of determining the patient's position for acquiring imaging and reference points. Bench testing of the SOLOPASS® . System verifies the PID design and performance to fulfill its intended use. These differences do not raise new questions of safety and effectiveness. | | Manually operated | Yes | Yes | Same | | Instrument/ Catheter compatibility | Catheters with 3.4mm or 2.8mm outer diameter | Does not specify limitation in instrument and/or catheter size compatibility | Different. The subject device specifies compatibility of instrument/ catheter sizes based on the design of | | | | | | | | | | the fixation component that limits the size of these devices. The predicate device does not have a similar component that would restrict the size of compatible instruments/ catheters. This difference does not impact the shared intended use and fundamental technology comparison between the subject and predicate devices. Performance testing verifies the compatible device sizes for the SOLOPASS®. Therefore, these differences do not raise new questions of safety and effectiveness. | | Localization method | Encoders on Patient Interface Device to track motion of instruments/ catheters | Localizers with adapters that attach to instruments to track position. Adhesive radiographic markers placed near craniotomy site. | Similar. Both devices include components designed to track position of instruments/ catheters to aid in their placement to the surgical site during procedures. The differences between the localization methods do not raise new questions of safety and effectiveness. | | Transducer Type | Phased array probe | Linear array probe, phased array probe | Same. Both systems offer phased array probes. The predicate device provides an additional linear array probe. | | Transducer Frequency | 5 MHz 1 transducer | 5-10 MHz Multiple transducers available | Similar. 5 MHz transducer frequency is offered in both systems. Predicate device provides additional | | | | | transducers with additional frequencies. These differences do not raise new questions of safety and effectiveness. | | Transducer Style | "Burr-hole" style (craniotomy) | "Burr-hole" style (craniotomy) | Same | | Acoustic Output Display & FDA Limits | Track 3 | Unknown | The subject device met acoustic output testing acceptance criteria and FDA guidelines. Any differences in acoustic output display are not expected to raise new questions of safety and effectiveness. | | Imaging Mode | B Mode | B Mode | Same | | General Safety and Effectiveness Information | 1. Total Image Depth 0-10 cm 2. Optimal Image Range 2.5 – 8 cm | 1. Total Image Depth 0-9cm 2. Optimal Image Range 0-5 cm | Similar. Based on information about the predicate device available for comparison, both systems have similar parameters with some differences in range. Electrical safety, EMC, acoustic output, verification, and validation testing support the performance of the subject device, that these differences do not raise new questions of safety or effectiveness. | | Accuracy | Targeting accuracy: +/- 3mm Imaging accuracy: +/- 2mm | Imaging accuracy: $±2mm1$ | Similar. The subject and predicate devices demonstrate similar imaging accuracy. SOLOPASS® has | | User Interfaces | Graphical touch screen, Foot switch | Graphical touch screen, Foot switch | additionally been verified for targeting accuracy to aid the surgeon in placing instruments/ catheters. This does not raise new questions of safety and effectiveness. | | Electrical Safety | Conformity to IEC 60601-1 IEC 60601-1-2 | Conformity to IEC 60601-1 IEC 60601-1-2 | Same | | Biocompatibility Patient Contacting Components | Conformity to ISO 10993-1 Limited contact (<24 hours) • Patient Interface Device (Anchor, etc.) • Ultrasonic probe used with sheath and acoustic gel | Conformity to ISO 10993-1 Limited contact (<24 hours) • Radiographic markers • Ultrasonic probe used with drape and acoustic gel | Similar. Both devices share common duration and type of intended tissue contact. Both devices satisfied applicable biocompatibility evaluation. Therefore, any differences in patient- contacting materials do not raise new questions of safety and effectiveness. | | Sterilization | PID: Sterile, single- use, Gamma Ultrasound Probe: Reusable, sterilized by user by VHP | Spheres: Sterile, single-use Ultrasound Probe: Reusable, cannot be sterilized, must be used with sterile drape Localizers and navigators: Autoclave | Similar. Both devices have components delivered sterile or non-sterile, and have met applicable acceptance criteria for sterilization validation. Therefore, any differences in sterility methods do not raise new questions of safety and effectiveness. | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ 1 Lindseth, Frank et al. "Accuracy evaluation of a 3D ultrasound-based neuronavigation system." Computer aided surgery : official journal of the International Society for Computer Aided Surgery vol. 7,4 (2002): 197-222. doi:10.1002/igs.10046 {10}------------------------------------------------ {11}------------------------------------------------ ## Nonclinical Testing Summary: The following performance data are provided in support of the substantial equivalence determination between the proposed device, SOLOPASS® System, and the predicate device, Sonowand Invite System (K083597, K112469). | | | Table 1 Summary of Non-Clinical Performance Data | |--|--|--------------------------------------------------| |--|--|--------------------------------------------------| | TEST | TITLE/TEST METHOD SUMMARY | RESULTS | |-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------| | Biocompatibility | | | | ISO 10993-5 | Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity | Non-cytotoxic | | ISO 10993-10 | Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization | Non-sensitizing Non-irritating | | ISO 10993-11 | Biological evaluation of medical devices – Part 11: Tests for systemic toxicity | Non-pyrogenic Negative for acute systemic toxicity | | ANSI/AAMI ST72, USP <85>, USP <161> | Bacterial endotoxins test | Pass, all samples demonstrated less than 2.15 Eu/device required for devices with cerebrospinal fluid contact | | Thermal, Electrical, Mechanical Safety | | | | IEC 60601-1/ ANSI AAM ES 60601-1 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | Pass | | IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral | Pass | | IEC 60601-2-37 | Particular Requirements for the safety of ultrasonic medical diagnostic and monitoring equipment. | Pass | | AIM 7351731 | Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers | Pass | | IEC/EN 60529 | Degrees of protection provided by enclosures (IPX7) | Pass | | Cleaning, Disinfection, Sterilization | | | | Ultrasound Probe Cleaning Validation | Validation of cleaning and disinfection method for reusable ultrasound probes. | Pass | | Ultrasound Probe VHP Sterilization Validation | Validation of VHP sterilization method for reusable ultrasound probes. | Pass, SAL 10-6 | | AAMI/ANSI/ISO 11137-1.11137-2 | Validation of gamma sterilization method for single-use PID. | Pass, SAL 10-6 | | Ship and Shelf Life Functional Test | Verify functional performance of device components following testing per ISTA 3A, ISO 11607-1, and shelf-life aging. | Pass PID Shelf life: 12 months | | Verification Bench Testing | | | | 2D Imaging Qualification | Verification of ultrasound requirements including imaging depth, image accuracy, active element check and other specifications. | Pass | | System Targeting Accuracy | Measure targeting accuracy. Acceptance criteria defined based on Reference Device, V-Guide for Ventriculostomies (K141559). | +/- 3mm target at 6cm | | System Imaging Accuracy | Measure imaging accuracy. | +/- 2mm target at 4cm-7cm | | Cranial Mounting Mechanical Testing | Verify performance of SOLOPASS® screw and anchor compared to Reference Device Medtronic Navigus Trajectory Guide Kit (K992304). Test methods based on ASTM F543. | Met acceptance criteria for: mean pullout strength of anchor, mean ratio of yield strength vs. insertion torque. | | Hardware Verification | Verify performance of system electrical design requirements in addition to electrical safety and EMC. | Pass | | Software Verification and Validation | | | | Software Verification and Validation | Demonstrate that all software requirements were appropriately implemented in the software. Software development process demonstrates conformity to IEC 62304. | Pass | | Design Validation | | | | Design validation study | Validation study in simulated use conditions to demonstrate that SOLOPASS® final design met user needs. | Pass, user needs were successfully validated | {12}------------------------------------------------ ## Conclusions: In summary, the SOLOPASS® System and predicate device, Sonowand Invite System (K083597, K112469), are substantially equivalent with respect to intended use. Non-clinical testing results support that the subject and predicate devices are substantially equivalent in function for use as neuro-navigation systems with intraoperative ultrasound imaging. The differences between the two devices do not raise new questions of safety and effectiveness.