(248 days)
Not Found
No
The device description and performance studies focus on mechanical stone extraction and do not mention any AI/ML components or capabilities.
Yes
The device is intended for the extraction of bile duct stones, which is a therapeutic intervention.
No
The device is intended for the extraction of bile duct stones, which is a therapeutic intervention, not a diagnostic one. While it's used in conjunction with "exploration," its primary function is active stone removal.
No
The device description clearly outlines physical components (cholangiography catheter, stone basket, adapter, connecting tube assembly) and describes a physical surgical procedure. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Nathanson Transcystic Bile Duct Stone Exploration Pack is a surgical tool used inside the body (in vivo) to physically remove bile duct stones. It is not used to analyze a specimen for diagnostic purposes.
The device is a surgical instrument used for a therapeutic procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Nathanson Transcystic Bile Duct Stone Exploration Pack is intended for extraction of bile duct stones via laparoscopic transcystic approach.
Product codes
LOR
Device Description
The Nathanson Transcystic Bile Duct Stone Exploration Pack is a pre-assembled device comprising of a cholangiography catheter, a flatwire stone basket, "Y" Tuohy-Borst adapter, and a connecting tube assembly with a stopcock. The device is used in a healthcare facility/hospital environment during common bile duct exploration procedures. The subject device requires a transcystic surgical approach by a clinician for the removal of bile duct stones. When complete removal of common bile duct stones cannot be achieved, alternative approaches such as endoscopic retrograde cholangiography with sphincterotomy (ERCP) may be considered. The subject device is provided sterile and for single-use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
biliary tract, renal pelvis and ureter (predicate device indication includes this, subject device is used for bile duct stones)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare facility/hospital environment, clinician
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
- 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.
- Catheter Tip to Shaft Tensile: (Zero Time and Three Year Accelerated Aging) Tensile load at 0 failure should be greater than or equal to 10 N. Test results met predetermined criteria.
- Catheter Hub to Shaft Tensile: (Zero Time and Three Year Accelerated Aging) - Tensile load at failure should be greater than or equal to 10 N. Test results met predetermined criteria.
- Catheter Kink and leakage: (Zero Time) Test articles shall not kink at a kink length of 188 mm. Furthermore, there shall be no leakage from the Tuohy-Borst Y-Connector during flow evaluation of the catheter assembly. Test results met predetermined criteria.
- Catheter Radiopacity: (Zero Time and Three Year Accelerated Aging) The radiopacity of each test article catheter shaft shall fall along the gradient of an aluminum X-ray step wedge gauge. Test results met predetermined criteria.
- Flatwire Extractor Proximal Solder Connection Tensile: (Zero Time) - Tensile load at failure should be greater than or equal to 10 N. Test results met predetermined criteria.
- Flatwire Extractor Distal Basket Assembly Tensile: (Zero Time) Tensile load at failure should be greater than or equal to 10 N. Test results met predetermined criteria.
- Flatwire Extractor Basket Deployment & Retrieval: (Zero Time) - Test articles shall successfully track, deploy, and retrieve a simulated stone through a tube bent at approximately 90 degrees, without damage to the test article. Test results met predetermined criteria.
- Catheter & Flatwire Extractor Dimensional & Surface Analysis: (Zero Time) the specified dimensional and specification requirement for each test articles shall be met. Test results met predetermined criteria.
- Extension Tube Hub to Shaft Tensile: The peak tensile load that the Female Luer Lock Adapter to extension tube connection and Male Luer Lock Adapter to extension tube connection shall be greater than or equal to 4.9 N. Test results met predetermined criteria.
- Clinical Study: A 2007 retrospective study evaluated 160 consecutive patients with bile duct stones (Taylor et al, 2007). The Nathanson Trancystic Bile Duct Stone Exploration Pack (previously known as Nathanson Basket Kit) was used for transcystic exploration when 1 cm diameter stones were observed in the common bile duct. 131 cases (82%) achieved successful laparoscopic common bile duct exploration (LCBDE). 29 cases required additional intervention (i.e., ERCP) to achieve clearance at the time of surgery. Major morbidity occurred in 13.8%, including biliary leak in 7.5% and one late biliary stricture (0.6%).
Key Metrics
- Clinical Study: 131 cases (82%) achieved successful laparoscopic common bile duct exploration (LCBDE). Major morbidity occurred in 13.8%, including biliary leak in 7.5% and one late biliary stricture (0.6%).
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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March 1, 2018
Cook Incorporated Colin Jacob Capital Equipment Specialist, Regulatory Affairs 750 Daniels Way, P.O. Box 489 Bloomington, Indiana 47402
Re: K171915
Trade/Device Name: Nathanson Transcystic Bile Duct Stone Exploration Pack Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary Catheter and Accessories Regulatory Class: II Product Code: LOR Dated: February 2, 2018 Received: February 5, 2018
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.
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 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,
Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The text is black and appears to be against a white background. The letters are clearly legible and evenly spaced.
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) K171915
Device Name
Nathanson Transcystic Bile Duct Stone Exploration Pack
Indications for Use (Describe)
The Nathanson Transcystic Bile Duct Stone Exploration Pack is intended for extraction of bile duct stones via laparoscopic transcystic approach.
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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Image /page/3/Picture/1 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, uppercase letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, uppercase letters on a darker red background. The registered trademark symbol is located to the right of the word "COOK".
510(k) Summary
COOK INCORPORATED OOMINGTON, IN 47404 U.S WWW.COOKMEDICAL.C
Nathanson Transcystic Bile Duct Stone Exploration Pack (21 CFR §807.92) Date Prepared: February 28, 2018
Submitted By:
Applicant: Contact: Secondary Contact: Applicant Address:
Cook Incorporated Colin Jacob Hui Ouyang, PhD, RAC Cook Incorporated P.O. Box 489 750 Daniels Way Bloomington, IN 47402 (812) 335-3575 x 104965 (812) 332-0281
Contact Phone Number: Contact Fax Number:
Device Information:
Trade Name: Nathanson Transcystic Bile Duct Stone Exploration Pack Common Name: Dislodger, Stone, Biliary Gastroenterology/Urology Classification Panel: Classification Name: Biliary Catheter and Accessories Regulation Class: Class II 21 CFR § 876.5010 Regulation: Product Code: LOR
Predicate Device:
- Wittich Nitinol Stone Basket (K902944)
Device Description:
The Nathanson Transcystic Bile Duct Stone Exploration Pack is a pre-assembled device comprising of a cholangiography catheter, a flatwire stone basket, "Y" Tuohy-Borst adapter, and a connecting tube assembly with a stopcock. The device is used in a healthcare facility/hospital environment during common bile duct exploration procedures. The subject device requires a transcystic surgical approach by a clinician for the removal of bile duct stones. When complete removal of common bile duct stones cannot be achieved, alternative approaches such as endoscopic retrograde cholangiography with sphincterotomy (ERCP) may be considered. The subject device is provided sterile and for single-use only.
4
Image /page/4/Picture/1 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 font in the upper portion of the logo, and the word "MEDICAL" is in white, sans-serif font in the lower portion of the logo.
COOK INCORPORATED 750 DANIELS WAY LOOMINGTON, IN 47404 U.S.A. WWW.COOKMEDICAL.COM
Indications for Use:
The Nathanson Transcystic Bile Duct Stone Exploration Pack is intended for extraction of bile duct stones via laparoscopic transcystic approach.
Comparison to Predicate:
The Nathanson Transcystic Bile Duct Exploration Pack and the predicate device, Wittich Nitinol Stone Basket (K902944), have the same intended use and share similar indication for use and principles of operation. The differences in technological characteristics do not raise different questions of safety and/or effectiveness when comparing to the predicate.
Substantial Equivalence Comparison:
| PREDICATE DEVICE | SUBJECT DEVICE | ||
|---|---|---|---|
| Wittich Nitinol Stone Basket | |||
| (K902944) | Nathanson Transcystic Bile Duct | ||
| Stone Exploration Pack | |||
| 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 bile duct stones via | ||
| transcystic approach. | |||
| One-time Use | Yes | IDENTICAL TO PREDICATE | |
| Duration of Use | Limited (≤ 24 hours) | IDENTICAL TO PREDICATE | |
| Imaging Technique to | |||
| Visualize Catheter In Situ | Fluoroscopy | IDENTICAL TO PREDICATE | |
| Surgical Approach | Nonoperative | Transcystic Surgical | |
| Compatible Instrument | Not specified | Laparoscopic cholangiography | |
| instrument clamp with a minimum 6 | |||
| Fr working channel | |||
| Allowing flushing of saline and | |||
| contrast material through | |||
| catheter | No | Yes | |
| Basket | Material | Nitinol | |
| (nickel and titanium alloy) | Stainless steel | ||
| Wire Configuration | six-wire bulb shape | four-wire bulb shape | |
| Length (cm) | 4.5 | 2.3 | |
| Outer Diameter when | |||
| Deployed (cm) | 2 | IDENTICAL TO PREDICATE | |
| Catheter / Sheath | Material | Radiopaque tetrafluoroethylene | Radiopaque nylon |
| Ink Markers | No | Yes | |
| Length (cm) | 24 (introducer sheath) | 70 (catheter component) | |
| Outer Diameter (Fr) | 12 | 5.5 |
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Image /page/5/Picture/1 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, bold letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, bold letters on a red background. The logo is simple and clean, and the red and white colors are eye-catching.
COOK INCORPORATED
750 DANIELS WAY
BLOOMINGTON, IN 47404 U.S.A.
PHONE: 812.339.2235 TOLL FREE: 800.457.4500
WWW.COOKMEDICAL.COM
| PREDICATE DEVICE | SUBJECT DEVICE | |
|---|---|---|
| Wittich Nitinol Stone Basket | ||
| (K902944) | Nathanson Transcystic Bile Duct | |
| Stone Exploration Pack | ||
| Additional Assembly | ||
| Components | dilator | "Y" Tuohy-Borst adapter, |
| connecting tube, stopcock | ||
| Packaging | Polyethylene-Polyester/Tyvek | IDENTICAL TO PREDICATE |
| Sterilization Method | Ethylene Oxide | IDENTICAL TO PREDICATE |
| Sterility Assurance Level | ||
| (SAL) | 10-6 | IDENTICAL TO PREDICATE |
Substantial Equivalence Comparison (continued):
Technological Characteristics:
The subject device, Nathanson Transcystic Bile Duct Stone Exploration Pack, was 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.
- ' Catheter
- Tip to Shaft Tensile (Zero Time and Three Year Accelerated Aging) Tensile load at 0 failure should be greater than or equal to 10 N. Test results met predetermined criteria.
- ロ Hub to Shaft Tensile (Zero Time and Three Year Accelerated Aging) - Tensile load at failure should be greater than or equal to 10 N. Test results met predetermined criteria.
- Kink and leakage (Zero Time) Test articles shall not kink at a kink length of 188 mm. Furthermore, there shall be no leakage from the Tuohy-Borst Y-Connector during flow evaluation of the catheter assembly. Test results met predetermined criteria.
- Radiopacity (Zero Time and Three Year Accelerated Aging) The radiopacity of ロ each test article catheter shaft shall fall along the gradient of an aluminum X-ray step wedge gauge. Test results met predetermined criteria.
6
Image /page/6/Picture/1 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is written in white, sans-serif font in the upper portion of the logo. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font.
COOK INCORPORATED
750 DANIELS WAY
BLOOMINGTON, IN 47404 U.S.A.
PHONE: 812.339.2235 TOLL FREE: 800.457.4500
WWW.COOKMEDICAL.COM
- Flatwire Extractor ■
- ם Proximal Solder Connection Tensile (Zero Time) - Tensile load at failure should be greater than or equal to 10 N. Test results met predetermined criteria.
- Distal Basket Assembly Tensile (Zero Time) Tensile load at failure should be ロ greater than or equal to 10 N. Test results met predetermined criteria.
- ם Basket Deployment & Retrieval (Zero Time) - Test articles shall successfully track, deploy, and retrieve a simulated stone through a tube bent at approximately 90 degrees, without damage to the test article. Test results met predetermined criteria.
- . Catheter & Flatwire Extractor
- Dimensional & Surface Analysis (Zero Time) the specified dimensional and ロ specification requirement for each test articles shall be met. Test results met predetermined criteria.
- . Extension Tube
- ם Hub to Shaft Tensile - The peak tensile load that the Female Luer Lock Adapter to extension tube connection and Male Luer Lock Adapter to extension tube connection shall be greater than or equal to 4.9 N. Test results met predetermined criteria.
- . Clinical Study
- ロ A 2007 retrospective study evaluated 160 consecutive patients with bile duct stones (Taylor et al, 2007). The Nathanson Trancystic Bile Duct Stone Exploration Pack (previously known as Nathanson Basket Kit) was used for transcystic exploration when 1 cm diameter stones were observed in the common bile duct. 131 cases (82%) achieved successful laparoscopic common bile duct exploration (LCBDE). 29 cases required additional intervention (i.e., ERCP) to achieve clearance at the time of surgery. Major morbidity occurred in 13.8%, including biliary leak in 7.5% and one late biliary stricture (0.6%).
Conclusion:
For these tests, all pre-determined acceptance criteria were met. The results of these tests show that the Nathanson Transcystic Bile Duct Stone Exploration Pack meets the design input requirements based on the intended use. Furthermore, these results support the conclusion that the Nathanson Transcystic Bile Duct Stone Exploration Pack does not raise different questions of safety or effectiveness and support a determination of substantial equivalence.