(444 days)
Not Found
No
The device description and performance studies focus on the physical and material properties of a catheter set, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for jejunal feeding and delivery of medication, which are therapeutic interventions.
No
Explanation: The device is intended for jejunal feeding and medication delivery, which are therapeutic interventions, not diagnostic ones.
No
The device description and performance studies clearly indicate that this is a physical medical device comprised of various hardware components (catheter, wire guide, dilator, etc.) and does not mention any software functionality.
Based on the provided information, the Barone Jejunostomy Catheter Set is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "jejunal feeding and delivery of medication" directly into the patient's jejunum. This is a therapeutic and delivery function, not a diagnostic one performed on samples outside the body.
- Device Description: The components described (catheter, wire guide, dilator, adapters, needles) are all designed for insertion into the body and facilitating the delivery of substances. They are not designed to analyze biological samples.
- Performance Studies: The performance studies focus on the physical properties and safety of the device for insertion and use within the body (tensile strength, fracture resistance, corrosion resistance, leakage, MRI compatibility, biocompatibility). These are typical performance tests for medical devices used in vivo, not for IVD devices which would focus on analytical performance (sensitivity, specificity, etc.).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any diagnostic output.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Barone Jejunostomy Catheter Set does not fit this description.
N/A
Intended Use / Indications for Use
The Barone Jejunostomy Catheter Set is intended for patients older than 12 years old requiring jejunal feeding and delivery of medication. The device can be placed via a surgically open or laparoscopic technique.
Product codes (comma separated list FDA assigned to the subject device)
KNT, PIO, OCY
Device Description
The Barone Jejunostomy Catheter Set is comprised of a jejunostomy catheter with a pre-loaded stiffening cannula, a Coons wire guide, a dilator, an enteral feeding adapter (funnel), two entry access needles, and a enteral transition connector. The Barone Jejunostomy Catheter is manufactured from polyether-urethane tubing. This catheter is a 10.2 Fr device with a proximal connector cap and a luer lock adapter, 6 distal sideports, a silicone suture wing, and a tapered distal tip; it has a length of 52 cm. The luer lock adapter is glued to the enteral feeding adapter (funnel) and thus is not functional for connecting to other devices. A 5.5 Fr polyethylene stiffener is also provided with the catheter and is matched for a transitional fit. The stiffener is designed with a pre-molded locking hub and a 0.035 inch diameter endhole.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Jejunal
Indicated Patient Age Range
older than 12 years old
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 following tests were performed to demonstrate that the proposed Barone Jejunostomy Catheter Set met the applicable design and performance requirements and support a determination of substantial equivalence.
- Tensile Testing (catheter, dilator, and enteral feeding adapter and enteral connector) -Testing demonstrated that the peak load value was greater than the predetermined acceptance criterion.
- Tensile Testing (catheter-matched stiffener, wire guide) - Testing demonstrated that the peak load value was greater than or equal to the predetermined acceptance criterion.
- Fracture Testing (wire guide) – Testing demonstrated that no signs of fracture were observed in the region of interest, according to the predetermined acceptance criterion.
- Corrosion Resistance (wire guide) - Testing demonstrated that there was no sign of corrosion that could affect the functional performance of the wire guide. The predetermined acceptance criterion was met.
- Resistance to Damage by Flex (wire guide) Testing demonstrated that there were no signs of defects or damage, including flaking or material loss, when subjected to repeated flexing. The predetermined acceptance criterion was met.
- Liquid leakage (enteral feeding adapter and enteral connector) – Testing demonstrated that the connection did not leak. The predetermined acceptance criterion was met.
- MRI Testing MRI compatibility was assessed by evaluating magnetic field interactions (displacement force and torque), artifact, and RF-induced heating. The Barone Jejunostomy Catheter and the Enteral Feeding Adapter (funnel) are MR Safe according to ASTM F2503.
- Misconnection Testing Testing shows that the connector should not provide a secure connection when forcefully assembled to any surface of the components of and should easily disengage from each connector of every other application category specified in ISO 80369-1:2010 or should a connection engage, then greater that 75% of the infusate should leak from the misconnection between the connector and the reference connector. Based on this testing, the potential for the misconnections in the following applications has been addressed in the labeling:
- Intravascular or hypodermic applications (such as female luer lock fittings or male luer slip fittings).
- Breathing systems and driving gases applications
- Torque Test (Catheter hub and enteral feeding adapter) Testing demonstrated that the peak load value was greater than the predetermined acceptance criterion.
- Liquid leakage (Catheter and enteral feeding adapter) – Testing demonstrated that the connection did not leak. The predetermined acceptance criterion was met.
- Biocompatibility Testing Testing (i.e., cytotoxicity, sensitization, intracutaneous, systemic toxicity, subacute intraperitoneal toxicity, genotoxicity, and subcutaneous implant) shows that the devices are biocompatible. In conformance with the applicable sections of ISO 10993-1, the predetermined acceptance criteria were met.
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.
Not Found
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
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 18, 2017
Cook Incorporated Erum B. Nasir Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404
Re: K160567
Trade/Device Name: Barone Jejunostomy Catheter Set Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: KNT, PIO, OCY Dated: April 20, 2017 Received: April 21, 2017
Dear Erum B. Nasir:
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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) K160567
Device Name Barone Jejunostomy Catheter Set
Indications for Use (Describe)
The Barone Jejunostomy Catheter Set is intended for patients older than 12 years old requiring jejunal feeding and delivery of medication. The device can be placed via a surgically open or laparoscopic technique.
Type of Use (Select one or both, as applicable)
| ☑ Research and/or Educational Purposes |
|---|
| ☐ Commercial Purposes |
X | 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/0 description: The image shows the Cook Medical logo. The word "COOK" is in white, bold, sans-serif font and is placed on a red background. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font, also on a red background. The red background is a rectangle shape.
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
510(k) SUMMARY
Barone Jejunostomy Catheter Set 21 CFR §807.92 Date Prepared: May 17, 2017
Submitted By:
Submission: Applicant: Contact: Applicant Address:
Traditional 510(k) Premarket Notification Cook Incorporated Erum Nasir Cook Incorporated 750 Daniels Way Bloomington, IN 47404 (812) 335-3575 x102607 (812) 332-0281
Contact Phone Number: Contact Fax Number:
Device Information:
Trade Name: Common Name: Classification Name: Classification Regulations:
Barone Jejunostomy Catheter Set
Tubes, Gastrointestinal (And Accessories) Gastrointestinal tube and accessories 21 CFR §876.5980, Product Codes KNT, PIO 21 CFR §876.1500, Product Codes OCY
Device Class/Classification Panel: Class II, Gastroenterology/Urology
Predicate Devices:
- Primary Predicate: Compat® Jejunostomy Feeding Tube Kit (K991668) ●
- Additional Predicate: Flexiflo Laparoscopic Jejunostomy Kit (K925102) ●
Device Description:
The Barone Jejunostomy Catheter Set is comprised of a jejunostomy catheter with a pre-loaded stiffening cannula, a Coons wire guide, a dilator, an enteral feeding adapter (funnel), two entry access needles, and a enteral transition connector. The Barone Jejunostomy Catheter is manufactured from polyether-urethane tubing. This catheter is a 10.2 Fr device with a proximal connector cap and a luer lock adapter, 6 distal sideports, a silicone suture wing, and a tapered distal tip; it has a length of 52 cm. The luer lock adapter is glued to the enteral feeding adapter (funnel) and thus is not functional for connecting to other devices. A 5.5 Fr polyethylene stiffener is also provided with the catheter and is matched for a transitional fit. The stiffener is designed with a pre-molded locking hub and a 0.035 inch diameter endhole.
4
Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in large, white, sans-serif font, stacked on top of the word "MEDICAL" in a smaller, white, sans-serif font. The text is set against a red background.
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
Indications for Use:
The Barone Jejunostomy Catheter Set is intended for patients greater than 12 years old requiring jejunal feeding and delivery of medication. The device can be placed via a surgically open or laparoscopic technique.
Comparison to Predicate Devices:
The Barone Jejunostomy Catheter Set and the predicate devices, the Compat® Jejunostomy Feeding Tube Kit (K991668) and the Flexiflo Laparoscopic Jejunostomy Kit (K925102), are substantially equivalent in that these devices have similar design and indications for use. Additionally, the proposed device has the same technological characteristics and methods of placement as those of the predicate devices. The differences between the subject device and the predicate devices include the materials, dimensions, number of sideports, retention mechanism, and included accessories.
Performance Data:
The following tests were performed to demonstrate that the proposed Barone Jejunostomy Catheter Set met the applicable design and performance requirements and support a determination of substantial equivalence.
- . Tensile Testing (catheter, dilator, and enteral feeding adapter and enteral connector) -Testing demonstrated that the peak load value was greater than the predetermined acceptance criterion.
- . Tensile Testing (catheter-matched stiffener, wire guide) - Testing demonstrated that the peak load value was greater than or equal to the predetermined acceptance criterion.
- . Fracture Testing (wire guide) – Testing demonstrated that no signs of fracture were observed in the region of interest, according to the predetermined acceptance criterion.
- . Corrosion Resistance (wire guide) - Testing demonstrated that there was no sign of corrosion that could affect the functional performance of the wire guide. The predetermined acceptance criterion was met.
- Resistance to Damage by Flex (wire guide) Testing demonstrated that there were no . signs of defects or damage, including flaking or material loss, when subjected to repeated flexing. The predetermined acceptance criterion was met.
- . Liquid leakage (enteral feeding adapter and enteral connector) – Testing demonstrated that the connection did not leak. The predetermined acceptance criterion was met.
5
Image /page/5/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 white, block letters in the upper portion of the logo. Below the word "COOK" is the word "MEDICAL" written in white, block letters against a black background.
- MRI Testing MRI compatibility was assessed by evaluating magnetic field interactions ● (displacement force and torque), artifact, and RF-induced heating. The Barone Jejunostomy Catheter and the Enteral Feeding Adapter (funnel) are MR Safe according to ASTM F2503.
- Misconnection Testing Testing shows that the connector should not provide a secure . connection when forcefully assembled to any surface of the components of and should easily disengage from each connector of every other application category specified in ISO 80369-1:2010 or should a connection engage, then greater that 75% of the infusate should leak from the misconnection between the connector and the reference connector. Based on this testing, the potential for the misconnections in the following applications has been addressed in the labeling:
- o Intravascular or hypodermic applications (such as female luer lock fittings or male luer slip fittings).
- o Breathing systems and driving gases applications
- Torque Test (Catheter hub and enteral feeding adapter) Testing demonstrated that the ● peak load value was greater than the predetermined acceptance criterion.
- . Liquid leakage (Catheter and enteral feeding adapter) – Testing demonstrated that the connection did not leak. The predetermined acceptance criterion was met.
- Biocompatibility Testing Testing (i.e., cytotoxicity, sensitization, intracutaneous, . systemic toxicity, subacute intraperitoneal toxicity, genotoxicity, and subcutaneous implant) shows that the devices are biocompatible. In conformance with the applicable sections of ISO 10993-1, the predetermined acceptance criteria were met.
Conclusion:
The results of these tests support a conclusion that the Barone Jejunostomy Catheter Set met the design input requirements based on the intended use and support the conclusion that this device does not raise new questions of safety or effectiveness and is substantially equivalent to the predicate devices, the Compat® Jejunostomy Feeding Tube Kit (K991668) and the Flexiflo Laparoscopic Jejunostomy Kit (K925102).