(59 days)
No
The summary describes a physical catheter for laser fiber delivery and protection, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a catheter intended for protection and delivery of a laser fiber; it does not directly treat a disease or condition itself.
No
The description states the device is intended for "protection and delivery of a laser fiber in the urinary tract," which is a therapeutic or interventional function, not diagnostic. There are no mentions of image processing, AI, or diagnostic performance metrics.
No
The device description clearly outlines physical components made of polyethylene tubing, Luer lock adapters, and connector caps, 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 "for protection and delivery of a laser fiber in the urinary tract." This describes a device used within the body for a therapeutic or procedural purpose, not for testing samples outside the body to diagnose a condition.
- Device Description: The description details a physical catheter designed for insertion into the urinary tract. This aligns with an in vivo medical device, not an in vitro diagnostic.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a disease or condition based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Laser Ureteral Catheter is intended for protection and delivery of a laser fiber in the urinary tract.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Laser Ureteral Catheter is a single lumen catheter available in a diameter of 7.1 French and a length of 40 centimeters. The Laser Ureteral Catheter is manufactured from polyethylene tubing, with a proximal female Luer lock adapter and connector cap, and male Luer lock adapter and connector cap with a cap seal. The device is provided sterile and intended for one-time use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract
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)
Performance - Testing shows that the subject device conforms to the performance testing requirements based on intended use. All predetermined acceptance criteria were met.
Tests Performed:
- Compatibility and Dimensional Testing
- Tensile Strength
- Radiopacity
- Kink Radius
Biocompatibility - Testing shows that the subject device conforms to the biocompatibility requirements based on its intended use. All predetermined acceptance criteria were met.
Tests Performed:
- Cytotoxicity – ISO MEM Elution
- Sensitization – Guinea Pig Maximization
- Irritation/Intracutaneous Reactivity - Intracutaneous Study
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.
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
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The Department of Health & Human Services logo is a stylized representation of a human figure, while the FDA part includes the acronym "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 30, 2018
Cook Incorporated Carly Powell Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404
Re: K181431
Trade/Device Name: Laser Ureteral Catheter Regulation Number: 21 CFR§ 878.4810 Regulation Name: Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology Regulatory Class: II Product Code: GEX Dated: May 31, 2018 Received: June 1, 2018
Dear Carly Powell:
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181431
Device Name Laser Ureteral Catheter
Indications for Use (Describe)
The Laser Ureteral Catheter is intended for protection and delivery of a laser fiber in the urinary tract.
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)
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
Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is written in large, white, sans-serif font at the top. Below "COOK" is the word "MEDICAL" in a smaller, white, sans-serif font.
2.0 510(k) Summary
750 DANIELS WAY, I
K181431 Page 1 of 5
Laser Ureteral Catheter 21 CFR 878.4810 Date Prepared: July 30, 2017
Cook Incorporated
Cook Incorporated
Carly Powell Karthik Pillai
Submitted By:
Submission: Applicant: Contact:
Applicant Address:
Contact Phone Number: Contact Fax Number:
Device Information:
750 Daniels Way Bloomington, IN 47404 (812) 335-3575 x104913 (812) 332-0281
Traditional 510(k) Premarket Notification
| Trade Name: | Laser Ureteral Catheter |
|---|---|
| Common Name: | Powered Laser Surgical Instrument |
| Classification Name: | Laser surgical instrument for use in general and plastic |
| surgery and in dermatology | |
| Classification Regulation: | 21 CFR 878.4810, Product Code GEX |
| Device Class/Classification Panel: | Class II, General & Plastic Surgery |
Predicate Device:
The Laser Ureteral Catheter is substantially equivalent to the following device:
- K960768 Laser Fiber Delivery/Cleaning Catheter (Cook Urological Inc.). The Laser Fiber Delivery/Cleaning Catheter is used to protect the delivery of a laser ablation fiber for periodic, intraoperative cleaning of charred, thermally degraded tissue from the laser fiber and for irrigation of the surgical site.
Reference Device:
- . K171662 Ureteral catheters are indicated for access and catheterization of the urinary tract, including the following applications:
- Delivery of contrast media
- I Drainage of fluids from the urinary tract
- Delivery of irrigation fluids to the urinary tract
- Navigation of a tortuous ureter
4
2
- . Access, advancement, or exchange of wire guides (open-ended catheters only)
- The Pediatric Ureteral Catheter is indicated for access and catheterization of the o urinary tract in pediatric patients, including the following applications:
- . Delivery of contrast media
- I Drainage of fluids from the urinary tract
- I Delivery of irrigation fluids to the urinary tract
- I Navigation of a tortuous ureter
Device Description:
The Laser Ureteral Catheter is a single lumen catheter available in a diameter of 7.1 French and a length of 40 centimeters. The Laser Ureteral Catheter is manufactured from polyethylene tubing, with a proximal female Luer lock adapter and connector cap, and male Luer lock adapter and connector cap with a cap seal. The device is provided sterile and intended for one-time use.
Indications for Use:
The Laser Ureteral Catheter is intended for protection and delivery of a laser fiber in the urinary tract.
Comparison to Predicate:
The Laser Ureteral Catheter and the predicate device, Laser Fiber Delivery/Cleaning Catheter (K960768), are substantially equivalent in indications for use; these devices have similar design, technological characteristics, construction and function. Both are catheters intended to protect the delivery of a laser fiber. The Laser Ureteral Catheter and the reference device Ureteral Catheter (K171662) are similar in dimension, material, and these devices are both used in the ureter.
The intended uses for the Laser Fiber Delivery/Cleaning Catheter (K960768), and the subject device Laser Ureteral Catheter are fundamentally identical; "intended to be used to protect and deliver a laser fiber". The predicate has a broader indication for general surgery, whereas the subject device is specifically indicated for the urinary tract. The addition of this specific indication for the use in urinary tract does not raise any new questions of safety and effectiveness, since predicate is indicated for general surgery. Additionally, the access and catheterization of the urinary tract using a ureteral catheter is supported by the reference device Ureteral Catheter (K171662). The subject device and the reference device, Ureteral Catheters (K171662), are both indicated to access and catheterize the urinary tract.
5
Cook Incorporated - Traditional 510(k) Laser Ureteral Catheter July 17, 2018
The subject and predicate device have similar intended uses, and therefore, no new questions of safety or effectiveness are raised. A comparison of the intended uses and technological characteristics of the subject, reference and predicate devices is provided in Table 2.0-1.
| PREDICATE DEVICE | REFERENCE DEVICE | SUBJECT DEVICE | |
|---|---|---|---|
| Laser Fiber Delivery/Cleaning | |||
| Catheter | Ureteral Catheters | Laser Ureteral Catheter | |
| Manufacturer | Cook Urological, Inc | Cook Incorporated | Cook Incorporated |
| 510(k) | K960768 | K171662 | Subject of this submission |
| Regulation | 21 CFR §878.4810 | ||
| Laser surgical instrument for use | |||
| in general and plastic surgery | |||
| and in dermatology. | 21 CFR §876.5130 | ||
| Catheter, Ureteral, General & Plastic | |||
| Surgery | 21 CFR §878.4810 | ||
| Laser surgical instrument for use in | |||
| general and plastic surgery and in | |||
| dermatology. | |||
| Product Code | GEX | KOD | GEX |
| Classification | II | II | Identical |
| Indications for | |||
| Use | The Laser Fiber | ||
| Delivery/Cleaning Catheter is | |||
| intended to be used to protect the | |||
| delivery of a laser ablation fiber | |||
| for periodic, intraoperative | |||
| cleaning of charred, thermally | |||
| degraded tissue from the laser | |||
| fiber and for irrigation of the | |||
| surgical site. The 5.7 Fr Laser | |||
| Fiber Delivery/Cleaning | |||
| Catheter will accept laser fibers | |||
| up to 1250 microns (0.050 inch). | |||
| The 8.0 Fr Laser Fiber | |||
| Delivery/Cleaning Catheter will | |||
| accept fibers up to 1500 microns | |||
| (0.060 inch). | Ureteral catheters are indicated for | ||
| access and catheterization of the | |||
| urinary tract, including the following | |||
| applications: | |||
| • Delivery of contrast media | |||
| · Drainage of fluids from the urinary | |||
| tract | |||
| • Delivery of irrigation fluids to the | |||
| urinary tract | |||
| • Navigation of a tortuous ureter | |||
| • Access, advancement, or exchange of | |||
| wire guides (open-ended catheters | |||
| only) | |||
| The Pediatric Ureteral Catheter is | |||
| indicated for access and catheterization | |||
| of the urinary tract in pediatric patients, | |||
| including the following applications: | |||
| • Delivery of contrast media | |||
| • Drainage of fluids from the urinary | |||
| tract | |||
| • Delivery of irrigation fluids to the | |||
| urinary tract | |||
| · Navigation of a tortuous ureter | The Laser Ureteral Catheter is | ||
| intended for protection and | |||
| delivery of a laser fiber in the | |||
| urinary tract. |
Table 2.0-1 Comparison Table
6
| PREDICATE DEVICE | REFERENCE DEVICE | SUBJECT DEVICE | |
|---|---|---|---|
| Laser Fiber | |||
| Delivery/Cleaning Catheter | Ureteral Catheters | Laser Ureteral Catheter | |
| Catheter | |||
| Diameter (Fr) | 5.7-accept fibers up to 1250 | ||
| microns (0.05 inch), | |||
| 8.0-accept fibers up to 1500 | |||
| microns (0.06 inch) | 3-9 | 7.1 | |
| Catheter | |||
| Length (cm) | 25-40 | 10, 15, 70, 85, 120 | 40 |
| Catheter | |||
| Material | Polyethylene | Radiopaque Polyvinyl chloride or | |
| Polyurethane Radiopaque tubing or | |||
| Polytetrafluoroethylene | Polyethylene Radiopaque Tubing | ||
| Maximum | |||
| shelf-life | |||
| (years) | Unknown | 3 | 3 |
| Sterilization | |||
| Method | EtO | EtO | Identical |
| Packaging | Tyvek-Poly pouch | Tyvek polyethylene peel-open pouch | Tyvek-PET/ LDPE |
Performance Data:
The subject device underwent the applicable testing listed below to ensure reliable design and performance under the testing parameters. Performance and biocompatibility testing were conducted in accordance with the following applicable FDA guidance documents to confirm the reliable performance of critical device characteristics.
- . Performance - Testing shows that the subject device conforms to the performance testing requirements based on intended use. All predetermined acceptance criteria were met.
| Test Performed | Guidance Document |
|---|---|
| Compatibility and Dimensional Testing – Testing ensures dimensional and | |
| compatibility requirements were met. | N/A |
| Tensile Strength – Testing shows that there should be no fracture of catheter shaft and | |
| hub-to-shaft. | |
| Radiopacity – Testing shows that the mean radiopacity met the acceptance criteria and | |
| evaluated radiopacity by subjecting the ureteral catheters to a comparative | |
| fluoroscopic evaluation. | |
| Kink Radius – Testing determined the kink radius of the ureteral catheter tubing. |
- . Biocompatibility - Testing shows that the subject device conforms to the biocompatibility requirements based on its intended use. All predetermined acceptance criteria were met.
4
7
5
| Testing Performed | Guidance Document |
|---|---|
| Cytotoxicity – ISO MEM Elution | Use of International Standard |
| ISO 10993-1, "Biological | |
| evaluation of medical devices - | |
| Part 1: Evaluation and testing | |
| within a risk management | |
| process" | |
| Sensitization – Guinea Pig Maximization | |
| Irritation/Intracutaneous Reactivity - Intracutaneous Study |
All predetermined acceptance criteria were met.
Conclusion:
The data included in this submission indicate that the subject device does not raise new questions of safety or effectiveness compared to the predicate device, Laser Fiber Delivery/Cleaning Catheter (K960768), which supports a determination of substantial equivalence.