(100 days)
Not Found
No
The summary mentions "software-controlled image processor" and "image signal processing module" but does not contain any terms or descriptions indicative of AI or ML technology. The software testing references standard medical device software guidance, not AI/ML-specific guidance.
Yes
The device is described as being "intended to establish a conduit during endoscopic urological procedures for the treatment and removal of urinary stones (kidney stones, fragments, and dust)." The term "treatment" clearly indicates a therapeutic purpose.
No.
The device is primarily intended for the treatment and removal of urinary stones, as well as establishing a conduit during endoscopic urological procedures. While it employs ureteroscopy for "endoscopic examination," this appears to be for guidance during the interventional procedure rather than for primary diagnosis. The "intended use" explicitly states "treatment and removal of urinary stones," and the "device description" reiterates its purpose to "allow physicians to locate kidney stones and to establish a conduit...for the treatment and removal of urinary stones." The phrase "various diagnostic and therapeutic procedures" is mentioned fleetingly in the second paragraph of the "intended use" but is not the primary stated purpose or function elaborated upon for the device itself.
No
The device description clearly states that the system includes both a sterile single-use steerable ureteral catheter (hardware) and a reusable software-controlled image processor (hardware with software). It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "establish a conduit during endoscopic urological procedures for the treatment and removal of urinary stones" and for "endoscopic examination of the urinary tract and the interior of the kidney." This describes a surgical and diagnostic imaging device used in vivo (within the body) for direct visualization and intervention.
- Device Description: The description details a steerable ureteral catheter and an image processor used in a surgical suite. It focuses on physical manipulation, irrigation, vacuum, and image processing for visualization during a procedure.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health status. This device's function is entirely focused on facilitating and visualizing a surgical procedure within the body.
N/A
Intended Use / Indications for Use
The CVAC Aspiration System and CVAC Image Processor consists of a sterile single use, steerable ureteral catheter and a reusable software-controlled image processor. It is intended to establish a conduit during endoscopic urological procedures for the treatment and removal of urinary stones (kidney stones, fragments, and dust). It employs flexible ureteroscopy within the urinary tract for endoscopic examination of the urinary tract and the interior of the kidney.
The steerable ureteral catheter is used for irrigation and aspiration of kidney stones and stone dust with dedicated irrigation and vacuum channels under ureteroscopy. The CVAC Aspiration System and CVAC Image Processor can be used with additional accessories to perform various diagnostic and therapeutic procedures.
Product codes
FED, FGB
Device Description
The single use CVAC Aspiration System and the reusable CVAC Image Processor are specialized devices designed to allow physicians to locate kidney stones and to establish a conduit during endoscopic urological procedures for the treatment and removal of urinary stones (kidney stones, fragments, and dust). The devices are used in a surgical suite and are compatible with standard hospital monitors, vacuum sources, and irrigation sources.
The CVAC Aspiration System is a sterile single-use steerable ureteral catheter employing ureteroscopy with built-in irrigation and vacuum functionality. Accessories provided with the CVAC Aspiration System include an introducer, a laser bridge, a trigger tie, a 3-way stopcock, and a vacuum port cap. The CVAC Aspiration System catheter is compatible with commercially available accessories for stone removal such as appropriately sized single-use laser fibers and stone baskets, which are inserted and used in the vacuum channel. The CVAC Aspiration System connects to the CVAC Image Processor via an attached video cable.
The CVAC Image Processor is a software-controlled, reusable and electrical image processor. The CVAC Image Processor is connected to a standard 110V hospital electrical outlet via a provided power cord. The internal carrier board inside the CVAC Image Processor houses the LED control circuit, the display interface, and supports electrical interconnect between the image signal processing module and the System-on-Module (SOM). This allows the CVAC Image Processor to generate a video signal compatible with standard hospital grade external monitors. Accessories provided with the CVAC Image Processor include a HDMI-to-DVI adapter, a HDMI cable, and a power cable.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ureteroscopy, Digital Video Technology (Color CMOS), Optical Illumination (LED)
Anatomical Site
Urinary tract, Kidney
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians in a surgical suite
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)
Performance Test, Bench: Results of extensive bench performance verification and validation testing confirm that the aspiration and irrigation and other device characteristics meet product specifications, and the device meets design input requirements.
Usability Assessment: A usability assessment was conducted to evaluate the User's understanding of the User Manuals and Quick Reference Guide when performing and asked about critical tasks during use of the CVAC Aspiration System and CVAC Image Processor. Results confirm that the acceptance criteria for usability have been met by intended users in the intended use environments. All participants were observed to safely perform all primary operating functions and critical tasks. The risk profile was acceptable, user training and User Manuals and Quick Reference Guide were interpreted correctly.
Biocompatibility Data: Biocompatibility testing was conducted for the CVAC Aspiration System and accessories as an external communicating device, tissue/bone/dentin contacting, limited duration exposure. Cytotoxicity (MEM Elution Method), Sensitization (Guinea Pig Maximization Test, Magnusson-Kligman Method), Irritation (Intracutaneous test), Acute Systemic Toxicity, Material Mediated Pyrogen Test (LAL Test) testing all resulted in passing test results. This conclusion is that the CVAC Aspiration is biocompatible and meets the requirements of ISO 10993-1.
Electrical Safety and Electromagnetic Compatibility: Electrical safety and electromagnetic compatibility (EMC) was successfully performed to applicable requirements of IEC 60601-1, IEC 60601-1-2, and IEC 60601-4-2.
Optical Testing: Optical testing was successfully performed to appliable requirements of ISO 8600-1, ISO 8600-3, ISO 8600-4 and ISO 8600-6.
Software: Software verification and validation testing were conducted, and documentation was provided as recommended by FDA guidance documents, "Content of Premarket Submissions for Device Software Functions," issued on June 14, 2023, and "Off-The-Shelf Software Use in Medical Devices," issued on August 11, 2023. Cybersecurity risk assessment was conducted in accordance with FDA guidance document, "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions," issued on September 27, 2023. The software complies with IEC 62304.
Sterilization: Sterilization validation studies using ethylene oxide (EtO) confirmed sterilization to a sterility assurance level (SAL) of 10-6. The sterilization process was validated in accordance with ANSI AAMI ISO 11135: 2014, Over-Kill Approach.
Packaging and Shelf Life: Packaging validation testing, including transportation and distribution testing, demonstrated the product packaging protects and maintains device integrity and functionality for the CVAC Aspiration System and CVAC Image Processor. It also confirmed that the product packaging maintained product sterility and supports a 12-month shelf life for the CVAC Aspiration System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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February 2, 2024
Calyxo, Inc. Diane Mandell Horwitz, Ph.D. Regulatory Consultant 4473 Willow Road. Suite 100 Pleasanton, CA 94588
Re: K233472
Trade/Device Name: CVAC Aspiration System and CVAC Image Processor Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FED, FGB Dated: January 4, 2024 Received: January 4, 2024
Dear Diane Mandell Horwitz:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Mark R. Kreitz -S
for Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K233472
Device Name
CVAC Aspiration System and CVAC Image Processor
Indications for Use (Describe)
The CVAC Aspiration System and CVAC Image Processor consists of a sterile single use, steerable ureteral catheter and a reusable software-controlled image processor. It is intended to establish a conduit during endoscopic urological procedures for the treatment and removal of urinary stones (kidney stones, fragments, and dust). It employs flexible ureteroscopy within the urinary tract for endoscopic examination of the urinary tract and the interior of the kidney.
The steerable ureteral catheter is used for irrigation of kidney stones and stone dust with dedicated irrigation and vacuum channels under ureteroscopy. The CVAC Aspiration System and CVAC Image Processor can be used with additional accessories to perform various diagnostic and therapeutic procedures.
| 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
GENERAL INFORMATION 1.
Submitter and 510(k) Owner 1.1
Calyxo, Inc. 4473 Willow Road, Suite 100 Pleasanton, CA 94588
1.2 Official Correspondent
Diane Horwitz, Ph.D. Regulatory Consultant 5 Lake Como Ct. Greenville SC 29609 Telephone: 703.307.2921 Email: diane.horwitz(@calyxoinc.com
Date of Preparation 1.3
January 11, 2024
2. NAME OF THE DEVICE
2.1.1 Trade/Proprietary Name
CVAC Aspiration System and CVAC Image Processor
2.1.2 Common/Usual Name
Endoscopic Access Overtube, Gastroenterology-Urology Ureteroscope and Accessories, Flexible/Rigid
2.1.3 Classification Information
| Classification Name: | Endoscope and Accessories |
|---|---|
| Classification Regulation: | 21 CFR 876.1500 |
| Class: | II |
| Product Code: | FED, Endoscopic Access Overtube, Gastroenterology-Urology |
| FGB, Ureteroscope and Accessories, Flexible/Rigid | |
| Panel: | Urology |
PREDICATE DEVICES 3.
The primary predicate device is the CVAC Aspiration System (formerly K-VAC Aspiration Catheter, Calyxo, Inc, K200149). The secondary predicate is Axis Single-Use Digital Flexible Ureteroscope (K180367, Shanghai AnQing Medical Instrument CO., Ltd.).
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4
4. DESCRIPTION OF THE DEVICE
The single use CVAC Aspiration System and the reusable CVAC Image Processor are specialized devices designed to allow physicians to locate kidney stones and to establish a conduit during endoscopic urological procedures for the treatment and removal of urinary stones (kidney stones, fragments, and dust). The devices are used in a surgical suite and are compatible with standard hospital monitors, vacuum sources, and irrigation sources.
The CVAC Aspiration System is a sterile single-use steerable ureteral catheter employing ureteroscopy with built-in irrigation and vacuum functionality. Accessories provided with the CVAC Aspiration System include an introducer, a laser bridge, a trigger tie, a 3-way stopcock, and a vacuum port cap. The CVAC Aspiration System catheter is compatible with commercially available accessories for stone removal such as appropriately sized single-use laser fibers and stone baskets, which are inserted and used in the vacuum channel. The CVAC Aspiration System connects to the CVAC Image Processor via an attached video cable.
The CVAC Image Processor is a software-controlled, reusable and electrical image processor. The CVAC Image Processor is connected to a standard 110V hospital electrical outlet via a provided power cord. The internal carrier board inside the CVAC Image Processor houses the LED control circuit, the display interface, and supports electrical interconnect between the image signal processing module and the System-on-Module (SOM). This allows the CVAC Image Processor to generate a video signal compatible with standard hospital grade external monitors. Accessories provided with the CVAC Image Processor include a HDMI-to-DVI adapter, a HDMI cable, and a power cable.
ട്. INTENDED USE
The intended use / indications for the CVAC Aspiration System and CVAC Image Processor is as follows:
The CVAC Aspiration System and CVAC Image Processor consists of a sterile single use, steerable ureteral catheter and a reusable software-controlled image processor. It is intended to establish a conduit during endoscopic urological procedures for the treatment and removal of urinary stones (kidney stones, fragments, and dust). It employs flexible ureteroscopy within the urinary tract for endoscopic examination of the urinary tract and the interior of the kidney.
The steerable ureteral catheter is used for irrigation and aspiration of kidney stones and stone dust with dedicated irrigation and vacuum channels under ureteroscopy. The CVAC Aspiration System and CVAC Image Processor can be used with additional accessories to perform various diagnostic and therapeutic procedures.
INTENDED USE COMPARED TO THE PREDICATE 6.
The intended use of the CVAC Aspiration System and CVAC Image Processor includes the combined intended uses of both predicate devices. The mode of operation is the same as the combined modes of action of both predicate devices but is based on the mode of action of the primary predicate. Placement procedures for the subject device and primary predicate are the same. The subject device provides visualization during the procedure, similar to the secondary predicate. The combination of the two capabilities provides a streamlined ability to remove kidney stones and stone dust.
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7. TECHNOLOGY CHARACTERISTICS COMPARED TO THE PREDICATE
There are similarities between the technological characteristics of CVAC Aspiration System and CVAC Image Processor and the primary predicate, and between the subject devices and the secondary predicate. Similarities to the primary predicate include the mode of use of the device, the working length, OD, ID, external catheter profile, the dedicated irrigation channel and aspiration channel and the functionality for irrigation of small kidney stones and stone dust.
Differences compared to the primary predicate include the built-in digital imaging in the subject device, the software controls and electronics, while the primary predicate relies on fluoroscopy for visualization. Additionally, the subject device has a hydrophilic coating to aid in placement.
The CVAC Aspiration System and CVAC Image Processor and the secondary predicate are similar in that both devices are flexible single-use sterile ureteroscopes designed to be used with one companion image processor. Both have visualization via a camera chip at the catheter tip, both are software-controlled and electronic. Table 1 below reviews the technological comparison between the subject device and both predicates.
The different technological characteristics between the subject device and the predicates have been evaluated and it has been determined the subject device does not raise new questions of safety and effectiveness. The sum of the technology of the primary predicate and the secondary predicate supports the substantial equivalence determination.
| | Subject Device
CVAC Aspiration System
and CVAC Image Processor | Primary Predicate
CVAC Aspiration System
K200419 | Secondary Predicate
Axis Disposable
Ureteroscope
K180367 |
|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Working
Length | 70 cm | 70 cm | 65 cm |
| Total Length | 100 cm | 90 cm | 92 cm |
| Shaft OD | 5000 lux |
Table 1. Technology Comparison of CVAC Aspiration System and CVAC Image Processor and Predicate Devices
6
Table 1. Technology Comparison of CVAC Aspiration System and CVAC Image Processor
and Predicate Devices
7
8. PERFORMANCE TESTING
The 510(k) submission provided performance data to establish the substantial equivalence of the CVAC Aspiration System and CVAC Image Processor (the subject device) to the predicate devices. A summary of these performance tests is provided below.
Performance Test, Bench: Results of extensive bench performance verification and validation testing confirm that the aspiration and irrigation and other device characteristics meet product specifications, and the device meets design input requirements.
Usability Assessment: A usability assessment was conducted to evaluate the User's understanding of the User Manuals and Quick Reference Guide when performing and asked about critical tasks during use of the CVAC Aspiration System and CVAC Image Processor. Results confirm that the acceptance criteria for usability have been met by intended users in the intended use environments. All participants were observed to safely perform all primary operating functions and critical tasks. The risk profile was acceptable, user training and User Manuals and Quick Reference Guide were interpreted correctly.
Biocompatibility Data: Biocompatibility testing was conducted for the CVAC Aspiration System and accessories as an external communicating device, tissue/bone/dentin contacting, limited duration exposure. Cytotoxicity (MEM Elution Method), Sensitization (Guinea Pig Maximization Test, Magnusson-Kligman Method), Irritation (Intracutaneous test), Acute Systemic Toxicity, Material Mediated Pyrogen Test (LAL Test) testing all resulted in passing test results. This conclusion is that the CVAC Aspiration is biocompatible and meets the requirements of ISO 10993-1.
Electrical Safety and Electromagnetic Compatibility: Electrical safety and electromagnetic compatibility (EMC) was successfully performed to applicable requirements of IEC 60601-1, IEC 60601-1-2, and IEC 60601-4-2.
Optical Testing: Optical testing was successfully performed to appliable requirements of ISO 8600-1, ISO 8600-3, ISO 8600-4 and ISO 8600-6.
Software: Software verification and validation testing were conducted, and documentation was provided as recommended by FDA guidance documents, "Content of Premarket Submissions for Device Software Functions," issued on June 14, 2023, and "Off-The-Shelf Software Use in Medical Devices," issued on August 11, 2023. Cybersecurity risk assessment was conducted in accordance with FDA guidance document, "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions," issued on September 27, 2023. The software complies with IEC 62304.
Sterilization: Sterilization validation studies using ethylene oxide (EtO) confirmed sterilization to a sterility assurance level (SAL) of 10°. The sterilization process was validated in accordance with ANSI AAMI ISO 11135: 2014, Over-Kill Approach.
Packaging and Shelf Life: Packaging validation testing, including transportation and distribution testing, demonstrated the product packaging protects and maintains device integrity and functionality for the CVAC Aspiration System and CVAC Image Processor. It also confirmed that the product packaging maintained product sterility and supports a 12-month shelf life for the CVAC Aspiration System.
CONCLUSIONS 9.
This 510(k) submission demonstrates that the CVAC Aspiration System and CVAC Image Processor is substantially equivalent to the predicate devices.