(14 days)
No
The 510(k) summary describes a set of mechanical tools for bile duct stone retrieval and cholangiography, with no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is used for bile duct stone retrieval, which is a therapeutic intervention.
No.
The device is described as an "Exploration Set" for "stone retrieval" and "cholangiography." Cholangiography is an imaging technique to visualize bile ducts, but the primary function indicated for this set is stone retrieval, which is a therapeutic intervention, not purely diagnostic. While it aids in visualization, its overall purpose leans towards treatment rather than solely diagnosis.
No
The device description explicitly lists multiple physical components (catheters, wire guide, extractor) that are part of the device set.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cholangiography and bile duct stone retrieval using fluoroscopy." This describes a procedure performed on the patient's body to visualize and remove stones.
- Device Description: The components listed (catheters, wire guide, stone extractor) are instruments used for a medical procedure within the body.
- IVD Definition: In Vitro Diagnostics are tests performed outside the body on samples such as blood, urine, or tissue to diagnose diseases or conditions.
This device is clearly an in vivo medical device used for a therapeutic and diagnostic procedure performed directly on the patient.
N/A
Intended Use / Indications for Use
The Strange Bile Duct Stone Exploration Set is intended to be used for cholangiography and bile duct stone retrieval using fluoroscopy. The device is indicated for adults only.
Product codes
LOR, GCD, GBZ, OCY, GCB
Device Description
The Strange Bile Duct Stone Exploration Set is provided sterile for single-use only. The set consists of:
- . a 115 centimeter long NCompass Nitinol Tipped Stone Extractor with Tuohy Borst adapter
- a 7.5 French, double lumen, 40 centimeter long radiopaque polyurethane cholangiography catheter with a preloaded inner catheter;
- . a 10 French, 12 centimeter long introducer catheter with preloaded needle stylet; and
- a 125 centimeter long, polytetrafluoroethylene coated wire guide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
Bile duct
Indicated Patient Age Range
adults only.
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)
The subject device, Strange Bile Duct Stone Exploration Set, was subjected to applicable nonclinical testing to assure reliable design and performance under the testing parameters. Testing includes:
- Dimensional and Compatibility Evaluation of subject device set (Accelerated Aged)
All pre-determined acceptance criteria were met.
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
§ 876.5010 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.
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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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 15, 2017
Cook Incorporated Colin Jacob Regulatory Affairs Specialist 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402
Re: K173687
Trade/Device Name: Strange Bile Duct Stone Exploration Set Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary Catheter and Accessories Regulatory Class: II Product Code: LOR, GCD, GBZ, OCY, GCB Dated: November 30, 2017 Received: December 1, 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. However, you are responsible to determine that the medical devices you use as components in the Strange Bile Duct Stone Exploration Set have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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.
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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 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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
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Indications for Use
510(k) Number (if known) K173687
Device Name Strange Bile Duct Stone Exploration Set
Indications for Use (Describe)
The Strange Bile Duct Stone Exploration Set is intended to be used for cholangiography and bile duct stone retrieval using fluoroscopy. The device is indicated for adults only.
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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K173687
Page 1 of 4
COOK
MEDICAL
750 DANIELS WAY, P.C
BLOOMINGTON, IN 47402-C
PHONE: 812.339.2235 TOLL FREE: 800
WWW.COOKMED
510(k) Summary
Strange Bile Duct Stone Exploration Set (21 CFR §807.92) Date Prepared: November 30, 2017
Submitted Bv:
Applicant: Contact: Applicant Address: Cook Incorporated Colin Jacob Cook Incorporated 750 Daniels Way Bloomington, IN 47402 (812) 335-3575 x 104965 (812) 332-0281
Device Information:
Contact Fax Number:
Contact Phone Number:
Trade Name: Panel: Regulation: Regulation Name: Primary Product Code: Secondary Product Codes:
Strange Bile Duct Stone Exploration Set Gastroenterology/Urology 21 CFR § 876.5010 Biliary catheter and accessories LOR GCD, GBZ, OCY, GCB
Predicate Devices:
The predicate device is the NCompass Nitinol Stone Extractor (K173009).
Device Description:
The Strange Bile Duct Stone Exploration Set is provided sterile for single-use only. The set consists of:
- . a 115 centimeter long NCompass Nitinol Tipped Stone Extractor with Tuohy Borst adapter
- a 7.5 French, double lumen, 40 centimeter long radiopaque polyurethane cholangiography catheter with a preloaded inner catheter;
- . a 10 French, 12 centimeter long introducer catheter with preloaded needle stylet; and
- a 125 centimeter long, polytetrafluoroethylene coated wire guide.
Indications for Use:
The Strange Bile Duct Stone Exploration Set is intended to be used for cholangiography and bile duct stone retrieval using fluoroscopy. The device is indicated for adults only.
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COOK
INCORPORATED
750 DANIELS WAY, P.O. BOX 489
BLOOMINGTON, IN 47402-0489 U.S.A..
PHONE: 812.339.2235 TOLL FREE: 800.457.4500
WWW.COOKMEDICAL.COM
Comparison to Predicates:
The Strange Bile Duct Exploration Set and the predicate device, the NCompass Nitinol Stone Extractor (K173009), are substantially equivalent in that these devices have the same intended use and principles of operation, and similar indications for use. The differences between the subject device and the predicate device include:
- . Additional components.
- " Assist in cholangiography via the additional components.
A comparison table on the following page elaborates on the features of the subject device and the predicate device.
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COOK INCORPORATED
750 DANIELS WAY, P.O. BOX 489
BLOOMINGTON, IN 47402-0489 U.S.A.
PHONE: 812.339.2235 TOLL FREE: 800.457.4500
WWW.COOKMEDICAL.COM
Substantial Equivalence Comparison
| PREDICATE DEVICE | SUBJECT DEVICE | ||
|---|---|---|---|
| NCompass Nitinol Stone | |||
| Extractor | |||
| (K173009) | Strange Bile Duct Stone | ||
| Exploration Set | |||
| Regulation Number | 21 CFR § 876.5010 | IDENTICAL TO PREDICATE | |
| Primary Product Code | LQR | IDENTICAL TO PREDICATE | |
| Classification | II | IDENTICAL TO PREDICATE | |
| Indications for Use | For extraction of stones or debris | ||
| during biliary surgical procedures | For cholangiography and bile duct | ||
| stone retrieval using fluoroscopy | |||
| One-time Use | Yes | IDENTICAL TO PREDICATE | |
| Duration of Use | Limited (≤ 24 hours) | IDENTICAL TO PREDICATE | |
| Principles of Operation | Basket deployment from sheath into | ||
| the biliary duct location | Basket deployment from sheath into | ||
| the biliary duct location. In addition | |||
| to cholangiography of the duct. | |||
| Imaging Technique to Visualize | |||
| Device | Fluoroscopy | IDENTICAL TO PREDICATE | |
| Tip Material | Stainless steel | IDENTICAL TO PREDICATE | |
| Wire Material | Nitinol | IDENTICAL TO PREDICATE | |
| Basket | Wire Configuration | 12-wire bulb configuration | IDENTICAL TO PREDICATE |
| Length (cm) | 1.9-2.3 | IDENTICAL TO PREDICATE | |
| Outer Diameter when | |||
| Deployed (cm) | 1.5 | IDENTICAL TO PREDICATE | |
| Catheter | Material | Braided stainless steel tubing coated | |
| with polytetrafluoroethylene | |||
| (PTFE), fluorinated ethylene | |||
| propylene (FEP), and polyimide | IDENTICAL TO PREDICATE | ||
| Length (cm) | 115 | IDENTICAL TO PREDICATE | |
| Outer Diameter (Fr) | 2.4 | IDENTICAL TO PREDICATE | |
| Adapter | Tuohy Borst adapter | IDENTICAL TO PREDICATE | |
| Additional Components | None | Cholangiography catheter, wire | |
| guide, introducer catheter with | |||
| preloaded needle stylet | |||
| Packaging | Polyethylene-Polyester/Tyvek | IDENTICAL TO PREDICATE | |
| Sterilization Method | Ethylene Oxide | IDENTICAL TO PREDICATE | |
| Sterility Assurance Level (SAL) | 10-6 | IDENTICAL TO PREDICATE |
Technological Characteristics:
The subject device, Strange Bile Duct Stone Exploration Set, was subjected to applicable nonclinical testing to assure reliable design and performance under the testing parameters. Testing includes:
- י Dimensional and Compatibility Evaluation of subject device set (Accelerated Aged)
All pre-determined acceptance criteria were met.
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Conclusion:
The Strange Bile Duct Stone Exploration Set meets the design input requirements based on the intended use. Furthermore, the results and comparison supports the conclusion that the Strange Bile Duct Stone Exploration Set does not raise new questions of safety or effectiveness and support a determination of substantial equivalence.