(92 days)
Not Found
No
The device description explicitly states that the catheter is mechanical and contains no electrical components. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is used for the treatment of urinary stones by assisting in the removal of stone fragments, which constitutes a therapeutic purpose.
No
The device is described as an aspiration-irrigation catheter used for the removal of stone fragments during urological procedures. Its function is to facilitate the physical removal of stones, not to diagnose a condition.
No
The device description clearly outlines a physical catheter with lumens, a steering mechanism, embedded wires, and an introducer. It also mentions being mechanical and containing no electrical components, further indicating it is a hardware device.
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 of urinary stones." This describes a surgical/interventional device used in vivo (within the body) to facilitate a procedure.
- Device Description: The description details a physical catheter used for irrigation and aspiration of stone fragments from the urinary tract. It's a mechanical device used to manipulate and remove material from the body.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) in vitro (outside the body) to provide diagnostic information about a patient's condition. IVDs are specifically designed for this purpose.
- Performance Studies: The performance studies focus on the mechanical and functional aspects of the catheter (flow, cycling, tortuosity, actuation, etc.) and its performance during a procedure (fluoroscopy time, procedure time, usability). These are typical performance metrics for surgical/interventional devices, not IVDs.
- Anatomical Site: The device is used within the urinary tract, which is an in vivo application.
In summary, the Kalera Vacuum Aspiration Catheter is a surgical/interventional device used to assist in the removal of urinary stones during a procedure. It does not perform any diagnostic testing on samples outside the body, which is the defining characteristic of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Kalera Vacuum Aspiration Catheter (K-VAC™) is used to establish a conduit during endoscopic urological procedures for the treatment of urinary stones.
Product codes (comma separated list FDA assigned to the subject device)
FED
Device Description
K-VAC is a sterile, single-use aspiration-irrigation catheter that is designed to assist in the removal of stone fragments during standard ureteroscopy. K-VAC is a dual-lumen catheter with two concentric lumens. The outer lumen is the irrigation lumen that accommodates delivery of irrigation/contrast solution. The larger, inner lumen is the aspiration lumen through which the stone fragments are removed. The inner diameter of the aspiration lumen is 2.5 mm. The distal 5 cm of the K-VAC tip is soft with a steering mechanism on the catheter handle and embedded wires to actuate the tip. In this way, stones and debris in the renal calyces can be fluidized with irrigation and aspirated.
An additional component to the device is a radiopaque introducer, which is 0.035" and 0.038" guidewire compatible. The tip of the introducer has a soft tapered tip.
The design of K-VAC allows the trained operator to maneuver and position K-VAC via a standard 12/14F ureteral access sheath under fluoroscopic guidance, followed by controlled irrigation and aspiration of stones and debris from the renal pelvis and calyces.
K-VAC is composed of well-characterized biocompatible materials commonly used in urinary catheters. The catheter is mechanical and contains no electrical components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
Anatomical Site
renal calyces, renal pelvis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained operator, hospital
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 (Laboratory Testing): Bench performance testing was performed to evaluate dimensional conformance, flow, product cycling, tortuous path testing, actuation testing, torque, and bond testing. Results of verification and validation testing confirm that the aspiration and irrigation and other device characteristics meet product specifications and the device meets design input requirements.
Performance Testing Animal: Testing with K-VAC and the predicate device in a GLP Animal Study evaluated device performance under fluoroscopy, irrigation and aspiration using a porcine model. Equivalent pathology and histopathology findings were observed between K-VAC and the predicate device; some observations in both groups were a result of the difficulty in establishing access in a tortuous porcine renal model and were not attributed to either device. Average overall fluoroscopy time and procedure time were substantially equivalent between K-VAC and the predicate device.
Usability Assessment: A usability assessment was conducted as a part of the GLP Animal Study, and confirmed that all participants were successful in all tasks during use of K-VAC.
Biocompatibility Data: Biocompatibility testing was conducted for K-VAC 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 leads to the conclusion that K-VAC is biocompatible and meets the requirements of ISO 10993-1.
Sterilization: Sterilization validation studies using ethylene oxide (EtO) confirmed sterilization to a sterility assurance level (SAL) of 106. 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 demonstrates the soundness of the product packaging to protect the device and maintain product sterility, integrity and functionality and supports a 12-month shelf life for K-VAC.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 22, 2020
Kalera Medical, Inc. % Diane Horwitz, Ph.D., RAC Regulatory Consultant Mandell Horwitz Consultants, LLC 5 Lake Como Ct. Greenville, SC 29609
Re: K200419
Trade/Device Name: Kalera Vacuum Aspiration Catheter™ (K-VACTM) Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FED Dated: April 27, 2020 Received: April 28, 2020
Dear Diane 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 (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.
1
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-regulatoryinformation/postmarketing-safety-reporting-combination-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,
Martha W. Betz, Ph.D. Acting 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)
Device Name
Kalera Vacuum Aspiration Catheter™ (K-VACTM)
Indications for Use (Describe)
The Kalera Vacuum Aspiration Catheter (K-VAC™) is used to establish a conduit during endoscopic urological procedures for the treatment of urinary stones.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
1. GENERAL INFORMATION
Submitter and 510(k) Owner 1.1
Kalera Medical, 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: dmh@mandellhorwitzconsulting.com
Date of Preparation 1.3
May 21, 2020
NAME OF THE DEVICE 2.
2.1.1 Trade/Proprietary Name
Kalera Vacuum Aspiration Catheter™ (K-VACTM)
2.1.2 Common/Usual Name
Endoscopic Access Overtube, Gastroenterology-Urology
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 |
| Panel: | Gastroenterology / Urology |
3. PREDICATE DEVICE
The predicate device is ClearPetra Suction-Evacuation Sheath (Well Lead Medical Co., Ltd., K161110).
4
4. DESCRIPTION OF THE DEVICE
K-VAC is a sterile, single-use aspiration-irrigation catheter that is designed to assist in the removal of stone fragments during standard ureteroscopy. K-VAC is a dual-lumen catheter with two concentric lumens. The outer lumen is the irrigation lumen that accommodates delivery of irrigation/contrast solution. The larger, inner lumen is the aspiration lumen through which the stone fragments are removed. The inner diameter of the aspiration lumen is 2.5 mm. The distal 5 cm of the K-VAC tip is soft with a steering mechanism on the catheter handle and embedded wires to actuate the tip. In this way, stones and debris in the renal calyces can be fluidized with irrigation and aspirated.
An additional component to the device is a radiopaque introducer, which is 0.035" and 0.038" guidewire compatible. The tip of the introducer has a soft tapered tip.
The design of K-VAC allows the trained operator to maneuver and position K-VAC via a standard 12/14F ureteral access sheath under fluoroscopic guidance, followed by controlled irrigation and aspiration of stones and debris from the renal pelvis and calyces.
K-VAC is composed of well-characterized biocompatible materials commonly used in urinary catheters. The catheter is mechanical and contains no electrical components.
ട. INTENDED USE
The intended use / indications for use for the Kalera Vacuum Aspiration Catheter (K-VAC) as follows:
The Kalera Vacuum Aspiration Catheter™ (K-VAC™) is used to establish a conduit during endoscopic urological procedures for the treatment of urinary stones.
INTENDED USE COMPARED TO THE PREDICATE 6.
The intended use of the Kalera Vacuum Aspiration Catheter (K-VAC) is the same as the predicate device. Both devices are used to establish a conduit for irrigation and aspiration of kidney stones during standard ureteroscopy, are composed of biocompatible materials, and are sterile single-use devices.
TECHNOLOGY CHARACTERISTICS COMPARED TO THE PREDICATE 7.
There are similarities and differences between the technological characteristics of K-VAC and the predicate device. The devices are similar in their use and purpose, as both devices are used to introduce irrigation to fluidize kidney stones and both devices remove stones using aspiration. A few features of the devices are different. Table 1 on the following page highlights the similarities and differences.
5
| | Subject Device
K-VAC
(Kalera Medical Inc.) | Predicate
ClearPetra K161110 | Similar / Different
Impact Safety and
Effectiveness |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Models and
Sizes | One model, two sizes
SKU KVAC60: 12F OD, 60
cm
SKU KVAC70: 12F OD, 70
cm | ClearPetra Ureteral Access
Sheath with 30 SKUs, ranging
from 10F to 14F ID, varying
lengths | Similar sizes, no impact on
safety or effectiveness |
| Design | Dual lumen catheter with
Aspiration Connector,
Irrigation Port and articulation
Control Lever. Radiopaque
introducer with a soft, tapered
tip. Inserted with introducer
over a guidewire under
fluoroscopy | Single lumen access sheath
with aspiration connector.
Irrigation via ureteroscope
Radiopaque introducer
Inserted with introducer over a
guidewire under fluoroscopy | Both devices are similar in the
use of luer adapters and
connectors, guidewires and
introducers, irrigation and
aspiration for stone removal
and use of fluoroscopy
The devices are different in
their steerability
This difference does not raise
any new issues of safety or
effectiveness as shown through
product testing |
| Lumen
Dimension(s) | Dual lumen device, compatible
with 12/14F standard ureteral
access sheaths
Outer lumen diameter (OD): 12F (4 mm) Inner lumen diameter (ID): 7.5F (2.5 mm) | Single lumen device
Sizes ranging from 10F (3
mm) to 14F (4.7 mm) | Same: K-VAC within size
range of predicate |
| Radiopacity | K-VAC and introducer are
radiopaque | ClearPetra and introducer are
radiopaque | Same |
| Irrigation | Via the Irrigation Port, a luer
fitting, using hospital supplies
Passive open system design
allowing continuous outflow
of irrigation fluid | Via the irrigation port of the
ureteroscope using hospital
supplies
Passive open system design
allowing continuous outflow
of irrigation fluid | Similar method of introducing
irrigation with the same goal
of fluidizing the kidney stones
and fragments
Same passive open system
design |
| Aspiration | May be used with standard
hospital vacuum sources at 150
to 200 mm Hg | May be used with standard
hospital vacuum sources at 150
to 200 mm Hg | Same |
| Steerability
via actuating
distal end | Control Lever can actuate the
distal 5 cm of the catheter 180°
to each side and can be rotated
to access areas of the renal
pelvis and calyces | Not steerable.
The ureteroscope inside the
sheath is steerable and actuates
similarly to the subject device | Differences between K-VAC
and the predicate devices
include:
Steerable tip A handle lever that
controls the actuation of
the tip Differences between subject
and predicate device were
shown not to impact safety or
effectiveness of the device.
Evidence comes from bench
design verification and
validation studies and GLP
animal study |
6
8. PERFORMANCE TESTING
The 510(k) submission provided performance data to establish the substantial equivalence of K-VAC (the subject device) to the predicate device. A summary of these performance tests is provided below.
Performance Test Bench (Laboratory Testing): Bench performance testing was performed to evaluate dimensional conformance, flow, product cycling, tortuous path testing, actuation testing, torque, and bond testing. Results of verification and validation testing confirm that the aspiration and irrigation and other device characteristics meet product specifications and the device meets design input requirements.
Performance Testing Animal: Testing with K-VAC and the predicate device in a GLP Animal Study evaluated device performance under fluoroscopy, irrigation and aspiration using a porcine model. Equivalent pathology and histopathology findings were observed between K-VAC and the predicate device; some observations in both groups were a result of the difficulty in establishing access in a tortuous porcine renal model and were not attributed to either device. Average overall fluoroscopy time and procedure time were substantially equivalent between K-VAC and the predicate device.
Usability Assessment: A usability assessment was conducted as a part of the GLP Animal Study, and confirmed that all participants were successful in all tasks during use of K-VAC.
Biocompatibility Data: Biocompatibility testing was conducted for K-VAC 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 leads to the conclusion that K-VAC is biocompatible and meets the requirements of ISO 10993-1.
Sterilization: Sterilization validation studies using ethylene oxide (EtO) confirmed sterilization to a sterility assurance level (SAL) of 106. 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 demonstrates the soundness of the product packaging to protect the device and maintain product sterility, integrity and functionality and supports a 12-month shelf life for K-VAC.
9. CONCLUSIONS
This 510(k) submission demonstrates that K-VAC is substantially equivalent to the predicate device.