(140 days)
510(k) Exempt
No
The device description and performance studies focus on mechanical and functional aspects of a catheter and stone removal basket/balloon, with no mention of AI or ML technologies.
Yes
The device is described as a stone removal catheter intended to grasp, manipulate, and remove calculi from the urinary tract, and for ureteral dilation, which are therapeutic interventions.
No
The device is described as a stone removal catheter used for grasping, manipulating, and removing calculi, and/or for ureteral dilation. Its function is to treat or intervene in a condition, not to diagnose it.
No
The device description clearly describes a physical catheter with a wire basket and balloon, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Peralta Stone Removal Catheter is a medical device used within the body (endoscopically) to physically manipulate and remove stones from the urinary tract and for dilation. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes a procedural intervention, not a diagnostic test performed on a sample.
Therefore, based on the provided information, the Peralta Stone Removal Catheter is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Peralta Stone Removal Catheter is intended to be used endoscopically to grasp, manipulate, and remove calculi from the urinary tract, and/or for ureteral dilation.
Product codes (comma separated list FDA assigned to the subject device)
FFL, EZN
Device Description
The Peralta Stone Removal Catheter (Peralta) is a 3 French (1 mm) catheter designed for removal of ureteral stones and fragments that are 5 mm or less in diameter in the urinary tract and ureteral dilation. The catheter uses a wire basket to encapsulate the stone, and a noncompliant balloon which can be inverted around the basket to cover the sharp edges of the stone during removal. The balloon can also be used for dilation of the urinary tract.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract, ureteral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-clinical testing:
Biocompatibility: The subject device was subjected to biocompatibility testing in compliance to ISO 10993-5 Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity and ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
Performance: The performance testing of the subject device included dimensional verification, functional and performance testing, usability testing, and mechanical testing. Ex vivo testing in porcine ureters was performed to simulate real world use of the device.
Animal Testing: In vivo testing on four ureters in a porcine model that incorporated preplaced urinary stones (3 mm and 4.3 mm in size) was performed to simulate real world use of the device when compared to a currently marketed device.
The results of these tests indicate that the Peralta Stone Removal Catheter is substantially equivalent to the predicate devices.
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.
510(k) Exempt
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
§ 876.4680 Ureteral stone dislodger.
(a)
Identification. A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 18, 2019
Calcula Technologies, Inc % Allison Komiyama Principal Consultant AcKnowledge Regulatory Strategies, LLC 2251 San Diego Avenue, Suite B-257 San Diego, CA 92110
Re: K190492
Trade/Device Name: Peralta Stone Removal Catheter Regulation Number: 21 CFR 876.4680 Regulation Name: Ureteral Stone Dislodger Regulatory Class: Class II Product Code: FFL, EZN Dated: June 7, 2019 Received: June 10, 2019
Dear Allison Komiyama:
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
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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,
Glenn B. Bell, Ph.D. Assistant Division 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
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Indications for Use
510(k) Number (if known)
Device Name Peralta Stone Removal Catheter
Indications for Use (Describe)
The Peralta Stone Removal Catheter is intended to be used endoscopically to grasp, manipulate, and remove calculi from the urinary tract, and/or for ureteral dilation.
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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510(k) Summary K190492
DATE PREPARED
July 18, 2019
MANUFACTURER AND 510(k) OWNER
Calcula Technologies, Inc. 959 Peralta Ave, San Francisco, CA 94110, USA Telephone: Official Contact: Raymond "Buzz" Bonneau, Chief Executive Officer
REPRESENTATIVE/CONSULTANT
Allison C. Komiyama, Ph.D., R.A.C. Lucie Dalet, Ph.D. AcKnowledge Regulatory Strategies, LLC Telephone: +1 (619) 458-9547 Email: akomiyama@acknowledge-rs.com, Idalet@acknowledge-rs.com Website: www.AcKnowledge-RS.com
DEVICE INFORMATION
| Proprietary Name/Trade Name: | Peralta Stone Removal Catheter |
|---|---|
| Common Name: | Dislodger, Stone, Basket, Ureteral, Meta |
| Regulation Description: | Ureteral stone dislodger |
| Regulation Number: | 21 CFR 876.4680 |
| Regulatory Class: | Class II |
| Product Code: | FFL, EZN |
| Premarket Review: | OPEQ/OHT3/DTH3B |
| Review Panel: | Gastroenterology/Urology |
PREDICATE DEVICE IDENTIFICATION
The Peralta Stone Removal Catheter is substantially equivalent to the following predicates:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---|---|---|
| K831875 | Balloon Dilation Helical Stone Extractor / VPI | ✓ |
| K941853 | Passport / Boston Scientific Corp | |
| 510(k) Exempt | Zero Tip Nitinol Stone Retrieval Basket / Boston Scientific Corp. | Reference Device |
The predicate devices have not been subject to a design related recall.
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Image /page/4/Picture/1 description: The image shows a logo for a company called "Calcula Technologies". The logo features a stylized image of a kidney with a flower-like design in the center. Above the logo, the text "K190492 page 2 of 3" is visible, likely indicating a document or page number.
DEVICE DESCRIPTION
The Peralta Stone Removal Catheter (Peralta) is a 3 French (1 mm) catheter designed for removal of ureteral stones and fragments that are 5 mm or less in diameter in the urinary tract and ureteral dilation. The catheter uses a wire basket to encapsulate the stone, and a noncompliant balloon which can be inverted around the basket to cover the sharp edges of the stone during removal. The balloon can also be used for dilation of the urinary tract.
INDICATIONS FOR USE
The Peralta Stone Removal Catheter is intended to be used endoscopically to grasp, manipulate, and remove calculi from the urinary tract, and/or for ureteral dilation.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Calcula believes that the Peralta Stone Removal Catheter is substantially equivalent to the predicate devices based on the information summarized here:
The subject device has a similar intended use and a similar design as the predicate device cleared in K831875, and similar dimensions and materials as the device cleared in K941853. The main differences between the primary predicate and subject devices are (1) the device cleared in K831875 features a helical basket made of four stainless steel wires and the subject device features a basket made of four nitinol wires and (2) the balloon of the subject device is able to invert around the captured stone and cover the sharp edges of the stone during removal. The technological characteristics of the subject device are similar in design, dimensions and materials, to the 510(k) exempt Zero Tip Nitinol Stone Retrieval Basket device marketed by Boston Scientific (reference device). The subject device has undergone testing to ensure that the device is substantially equivalent to the predicate and reference devices.
SUMMARY OF NON-CLINICAL TESTING
The Peralta Stone Removal Catheter conforms to the performance specifications outlined in FDA guidance document Checklist for Mechanical Lithotripters and Stone Dislodgers used in Gastroenterology and Urology (Issued November 01, 1994)
The following tests were performed to demonstrate safety based on current industry standards:
Biocompatibility: The subject device was subjected to biocompatibility testing in compliance to ISO 10993-5 Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity and ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
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Image /page/5/Picture/1 description: The image contains the logo for "Calcula Technologies". The logo features a stylized kidney graphic on the left, followed by the word "Calcula" in large, bold font. Below "Calcula" is the word "TECHNOLOGIES" in a smaller font. In the upper right corner of the image, the text "K190492 page 3 of 3" is visible.
Performance: The performance testing of the subject device included dimensional verification, functional and performance testing, usability testing, and mechanical testing. Ex vivo testing in porcine ureters was performed to simulate real world use of the device.
Animal Testing: In vivo testing on four ureters in a porcine model that incorporated preplaced urinary stones (3 mm and 4.3 mm in size) was performed to simulate real world use of the device when compared to a currently marketed device.
The results of these tests indicate that the Peralta Stone Removal Catheter is substantially equivalent to the predicate devices.
SUMMARY OF CLINICAL TESTING
No clinical data were provided in order to demonstrate substantial equivalence.
CONCLUSION
Non-clinical testing (including biocompatibility, dimensional verification, functional and performance testing, usability and human factors testing, and mechanical testing) has been performed to demonstrate that any differences in technological characteristics do not raise new issues of safety or effectiveness. The similar indications for use, technological characteristics, and performance characteristics for the proposed Peralta Stone Removal Catheter are assessed to be substantially equivalent to the predicate devices and the reference device.