(41 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical stone extraction device, with no mention of AI or ML capabilities.
No
The device is used for the extraction of stones, which is an intervention to remove pathology, not to treat a disease.
No
The device is described as a stone extractor intended for the extraction of stones or debris. Its function is to retrieve obstructions, not to diagnose medical conditions or identify diseases.
No
The device description explicitly states it is a physical, single-use, sterile, disposable device consisting of a nitinol basket, sheath, and Touhy-Borst adapter. The performance studies also focus on physical properties and biocompatibility.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The NCompass Nitinol Stone Extractor is a surgical tool used within the body to physically remove stones or debris during a procedure. It does not analyze biological samples outside the body.
- Intended Use: The intended use clearly states "extraction of stones or debris during biliary surgical procedures," which is a therapeutic/interventional function, not a diagnostic one.
The device is an interventional medical device used in a surgical setting.
N/A
Intended Use / Indications for Use
The NCompass Nitinol Stone Extractors are intended for extraction of stones or debris during biliary surgical procedures.
Product codes
LQR
Device Description
The NCompass Nitinol Stone Extractor is a single-use, sterile, disposable device. The extractor is a stone retrieval device consisting of nitinol basket with a 1.5 cm wide diameter when fully expanded and a 2.4 Fr shaft diameter sheath. The device is packaged with a Touhy-Borst adapter accessory.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy, Choledochoscope Imaging
Anatomical Site
biliary 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
The subject devices, NCompass Nitinol Stone Extractors, were subjected to applicable testing to assure reliable design and performance under the testing parameters. The tests are listed below:
- Biocompatibility - Per ISO 10993-1, testing for cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, and material-mediated pyrogenicity were performed to ensure the biocompatibility of the subject device set. Test results indicated that all materials are biocompatible.
- Dimensional and Compatibility Evaluation (Accelerated Aged)
- Radiopacity Evaluation (Accelerated Aged)
- Multiple Stone Retrieval Testing (Zero Time)
- Tensile Test: Basket Formation (Accelerated Aged)
- Tensile Test: Basket Coil (Accelerated Aged)
- Tensile Test: Basket Sheath (Accelerated Aged)
- Tensile Test: Basket Sheath to Handle Connection (Accelerated Aged)
- Tensile Test: Basket Assembly to Shaft Connection (Accelerated Aged)
- Tensile Test: Cannula to Basket Coil Connection (Accelerated Aged)
Key Results: For these tests, all pre-determined acceptance criteria were met. The results of these tests show that the NCompass Nitinol Stone Extractors meet the design input requirements based on the intended use. Furthermore, these results support the conclusion that the NCompass Nitinol Stone Extractors do not raise new questions of safety or effectiveness and support a determination of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 7, 2017
Cook Incorporated Colin Jacob Regulatory Affairs Specialist 750 Daniels Way P.O. Box 489 Bloomington, Indiana 47402
Re: K173009
Trade/Device Name: NCompass Nitinol Stone Extractors Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: Class II Product Code: LOR Dated: September 27, 2017 Received: September 27, 2017
Dear Colin Jacob:
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. 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
1
manufacturing practice requirements as set forth in the quality systems (OS) 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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.
Benjamin R. Fisher -S
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) K173009
Device Name NCompass Nitinol Stone Extractors
Indications for Use (Describe)
The NCompass Nitinol Stone Extractors are intended for extraction of stones or debris during biliary surgical 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)
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
NCompass Nitinol Stone Extractors (21 CFR §876.5010) Date Prepared: September 27, 2017
Submitted By:
| Applicant: | Cook Incorporated |
|---|---|
| Contact: | Colin Jacob |
| Applicant Address: | Cook Incorporated |
| P.O. Box 489 | |
| 750 Daniels Way | |
| Bloomington, IN 47402 | |
| Contact Phone Number: | (812) 335-3575 x 104965 |
| Contact Fax Number: | (812) 332-0281 |
Contact Fax Number:
Device Information:
| Trade Name: | NCompass Nitinol Stone Extractor |
|---|---|
| Common Name: | Dislodger, Stone, Biliary |
| Classification Name/Panel: | Gastroenterology/Urology |
| Regulation: | 21 CFR § 876.5010 |
| Regulation Name: | Biliary Catheter and Accessories |
| Product Code: | LQR |
Predicate Device:
- 트 Wittich Nitinol Stone Basket (K902944)
Device Description:
The NCompass Nitinol Stone Extractor is a single-use, sterile, disposable device. The extractor is a stone retrieval device consisting of nitinol basket with a 1.5 cm wide diameter when fully expanded and a 2.4 Fr shaft diameter sheath. The device is packaged with a Touhy-Borst adapter accessory.
Indications for Use:
The NCompass Nitinol Stone Extractors are intended for extraction of stones or debris during biliary surgical procedures.
Comparison to Predicate:
The NCompass Nitinol Stone Extractors and the predicate device, Wittich Nitinol Stone Basket (K902944), have the same intended use; they also share similar indications for use and principle
4
Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in white, sans-serif, uppercase letters in the top portion of the logo. Below that, the word "MEDICAL" is in white, sans-serif, uppercase letters in a smaller font size.
of operation. The differences in technological characteristics do not raise different questions of safety and/or effectiveness when compared to the predicate device.
Substantial Equivalence Comparison
| PREDICATE DEVICE | SUBJECT DEVICE | ||
|---|---|---|---|
| Wittich Nitinol Stone Basket | |||
| (K902944) | NCompass Nitinol Stone Extractor | ||
| Regulation Number | 21 CFR § 876.5010 | IDENTICAL TO PREDICATE | |
| Product Code | LQR | IDENTICAL TO PREDICATE | |
| Classification | II | IDENTICAL TO PREDICATE | |
| Indications for Use | For nonoperative removal of stones | ||
| from the biliary tract, renal pelvis and | |||
| ureter | For extraction of stones or debris during | ||
| biliary surgical procedures. | |||
| One-time Use | Yes | IDENTICAL TO PREDICATE | |
| Duration of Use | Limited (≤ 24 hours) | IDENTICAL TO PREDICATE | |
| Principle of Operation | Basket deployment from sheath into an | ||
| anatomical duct | IDENTICAL TO PREDICATE | ||
| Imaging Technique to Visualize | |||
| Device | Fluoroscopy | NC3 model: IDENTICAL TO | |
| PREDICATE | |||
| NCT4 model: Choledochoscope Imaging | |||
| Basket | Fluoroscopic Radiopaque | ||
| Material | Tungsten/Rhenium band | ||
| (located on sheath tip) | Stainless Steel | ||
| (located only on NC3 basket tip) | |||
| Tip Material | None (tipless) | NC3 model: Stainless steel | |
| NCT4 model: None (tipless) | |||
| Wire Material | Nitinol (nickel and | ||
| titanium alloy) | IDENTICAL TO PREDICATE | ||
| Wire Configuration | 6-wire bulb shape | 12-wire and 16-wire bulb shape | |
| Length (cm) | 4.5 | NC3 model: 1.9-2.3 | |
| NCT4 model: 2.1-2.5 | |||
| Outer Diameter when | |||
| Deployed (cm) | 2 | 1.5 | |
| Catheter / Sheath | Material | Radiopaque tetrafluoroethylene | Braided stainless steel tubing coated |
| with Polytetrafluoroethylene (PTFE), | |||
| fluorinated ethylene propylene (FEP), | |||
| and Polyimide | |||
| Length (cm) | 24 | 115 | |
| Outer Diameter (Fr) | 12 | 2.4 | |
| Additional Components | Dilator, introducer sheath | Handle, Touhy-Borst Adapter | |
| Packaging | Polyethylene-Polyester/Tyvek | IDENTICAL TO PREDICATE | |
| Sterilization Method | Ethylene Oxide | IDENTICAL TO PREDICATE | |
| Sterility Assurance Level (SAL) | 10-6 | IDENTICAL TO PREDICATE |
5
Image /page/5/Picture/0 description: The image is the logo for Cook Medical. The logo consists of the word "COOK" in large, white, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in a smaller, white, sans-serif font on a darker red background.
Technological Characteristics:
The subject devices, NCompass Nitinol Stone Extractors, were subjected to applicable testing to assure reliable design and performance under the testing parameters. The tests are listed below:
- . Biocompatibility - Per ISO 10993-1, testing for cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, and material-mediated pyrogenicity were performed to ensure the biocompatibility of the subject device set. Test results indicated that all materials are biocompatible.
- Dimensional and Compatibility Evaluation (Accelerated Aged) 트
- Radiopacity Evaluation (Accelerated Aged) .
- . Multiple Stone Retrieval Testing (Zero Time)
- Tensile Test: Basket Formation (Accelerated Aged) 트
- . Tensile Test: Basket Coil (Accelerated Aged)
- . Tensile Test: Basket Sheath (Accelerated Aged)
- 트 Tensile Test: Basket Sheath to Handle Connection (Accelerated Aged)
- 트 Tensile Test: Basket Assembly to Shaft Connection (Accelerated Aged)
- Tensile Test: Cannula to Basket Coil Connection (Accelerated Aged) 트
Conclusion:
For these tests, all pre-determined acceptance criteria were met. The results of these tests show that the NCompass Nitinol Stone Extractors meet the design input requirements based on the intended use. Furthermore, these results support the conclusion that the NCompass Nitinol Stone Extractors do not raise new questions of safety or effectiveness and support a determination of substantial equivalence.