(67 days)
No
The device description and intended use focus on mechanical components for enteral feeding and decompression, with no mention of AI or ML capabilities.
Yes
The device is intended to provide nutrition directly into a patient's stoma or stomach, which serves a therapeutic purpose by supporting health and well-being in patients unable to consume nutrition conventionally.
No
The device is intended to provide nutrition and stomach decompression, not to diagnose a medical condition.
No
The device description clearly indicates that the submission is for changes to physical accessories (Y-Port and Bolus/Decompression accessories) used with feeding tubes, which are hardware components. There is no mention of software as the primary or sole component of the device.
Based on the provided text, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use of all the listed devices is to provide nutrition or decompression directly into a patient's body (stoma or stomach). This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The description focuses on the physical components and connections of feeding tubes and accessories used for delivering substances into the body. It does not mention any components or processes related to analyzing samples from the body (like blood, urine, tissue, etc.) to diagnose a condition.
- Performance Studies: The performance studies described are related to the physical integrity and functionality of the connectors and tubes (tensile strength, flow rate, leakage, misconnection assessment), which are relevant to the safe and effective delivery of nutrition or decompression, not to diagnostic testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. The devices described here are used for direct patient care and support, not for analyzing samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The One Step Button device is intended to provide nutrition to a patient directly into the stoma. It is indicated for use on patients who are unable to consume nutrition by conventional means.
The EndoVive Low Profile Replacement Button Gastrostomy device is intended to provide nutrition to a patient directly into the stomach through a stoma. It is indicated for use on patients who are unable to consume nutrition by conventional means.
The Right Angle Feeding Set is intended to provide nutrition to a patient directly into the stomach through a gastrostomy tube. It is indicated for use on patients who are unable to consume nutrition by conventional means.
The Bolus Feeding Set is intended to provide nutrition to a patient directly into the stomach through a gastrostomy tube. It is indicated for use on patients who are unable to consume nutrition by conventional means.
The Right Angle Decompression Tube is intended to provide stomach decompression through a gastrostomy tube. It is indicated for use on patients who require enteral feeding as a means of nutritional support
Product codes (comma separated list FDA assigned to the subject device)
PIF
Device Description
The purpose of this Traditional 510(k) is to demonstrate that the proposed changes to the Y-Port and Bolus/Decompression accessories that are included in the devices identified above do not raise new questions of safety or effectiveness and that the devices are substantially equivalent to the currently marketed EndoVive™ Button kit and Accessory products.
The Y-Port and Bolus/Decompression accessories that are included in the devices identified above have two connections. One is located the distal end and the other is at the proximal end. The connector on the proximal end is identical in design to the ENFit threaded connector of the Y-Port accessory which was cleared via K150679. The Y-Port and Bolus/Decompression accessories are also identical in materials to the Y-Port device which was cleared via K150679. All of the performance and biocompatibility testing that was presented in K150679 to support the ENFit threaded connector is applicable to the Y-Port and Bolus/Decompression accessories of the proposed device. The scope of this submission is to demonstrate that the changes to the distal end of the Y-Port and Bolus/Decompression accessories are substantially equivalent to the predicate device. Neither the Button feeding tube nor the accessories used for tube placement within these kits is changing. The Button feeding tube and placement accessories in the kits are identical to the predicates.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
stoma, stomach
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)
The Endo Vive Button Kit with ENFit and Accessories have been tested according to the following standards:
- AAMI CN3:2014 (PS)/ ISO/DIS 80369-3.2 Small bore connectors for liquids and . gases in healthcare applications - Part 3: Connectors for enteral applications
- . AAMI CN20:2014 (PS)/ ISO 80369-20 gases in healthcare applications - Part 20: Common test methods
The information presented in this submission to support substantial equivalence of the Endo Vive Button Kit with ENFit and Accessory with ENFit Connector to the legally marketed predicate devices include: device description, indications for use, device comparison, material information, and labeling. Bench testing of the connector ISO/DIS 80369-3.2 ENFit thread design supports compliance to the material, and non-interconnectability, principles of the ISO 80369-1: 2010 standard. This performance assessment includes Risk analysis, Enteral Connector Misconnection Assessment, Enteral Connector Risk Management Report, Human Factors Validation Study, and ENFit Misconnection data with FMEA, tensile strength, flow rate, and liquid leakage.
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
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three figures representing people. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 17, 2016
Boston Scientific Corporation Virginia Garcia, MPP, RAC Principal, Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752
Re: K161003
Trade/Device Name: EndoVive™ One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, Endovive™ Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, Endovive™ Button Right Angle Feeding Set with ENFit Connector, Endovive Button Bolus Feeding Set with ENFit Connector, Endovive Button Decompression Tube with ENFit Connector Regulation Number: 21 CFR& 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: PIF Dated: April 8, 2016 Received: April 11, 2016
Dear Virginia Garcia:
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 Endovive One Step Button Low Profile Initial Placement Peg Kit with ENFit Connector and Endovive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector 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
1
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 (reporting of medical devicerelated 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.
In addition, we have determined that your device kits contain an antiseptic ointment packet and iodine swabs, which are subject to regulation as drugs.
Our substantially equivalent determination does not apply to the drug components of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug components. For information on applicable Agency requirements for marketing these drugs, we suggest you contact:
Center for Drug Evaluation and Research Office of Compliance 10903 New Hampshire Avenue Bldg. 51, Rm 5271 Silver Spring, MD 20993-0002
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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.
2
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -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
3
Indications for Use
510(k) Number (if known) K161003
Device Name
EndoVive™ One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, Endovive™ Low Profile Button Replacement Gastrostomy Tube Kit with Connector, Endovive™ Button Right Angle Feeding Set with ENFit Connector, Endovive™ Button Bolus Feeding Set with ENFit Connector, Endovive™ Button Decompression Tube with ENFit Connector
Indications for Use (Describe)
The One Step Button device is intended to provide nutrition to a patient directly into the stoma. It is indicated for use on patients who are unable to consume nutrition by conventional means.
The EndoVive Low Profile Replacement Button Gastrostomy device is intended to provide nutrition to a patient directly into the stomach through a stoma. It is indicated for use on patients who are unable to consume nutrition by conventional means.
The Right Angle Feeding Set is intended to provide nutrition to a patient directly into the stomach through a gastrostomy tube. It is indicated for use on patients who are unable to consume nutrition by conventional means.
The Bolus Feeding Set is intended to provide nutrition to a patient directly into the stomach through a gastrostomy tube. It is indicated for use on patients who are unable to consume nutrition by conventional means.
The Right Angle Decompression Tube is intended to provide stomach decompression through a gastrostomy tube. It is indicated for use on patients who require enteral feeding as a means of nutritional support
| 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) |
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."
4
Button
Tube
Boston Scientific Corporation K920894
KNT
Decompression
1. Submitter
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4430 Fax: 508-683-5939
Contact: Virginia Garcia, MPP, RAC Principal, Regulatory Affairs Specialist
Date Prepared: April 8, 2016
2. Devices
Trade Name:
Endo Vive™ One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector Endovive™ Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector Endovive™M Button Right Angle Feeding Set with ENFit Connector Endovive™ Button Bolus Feeding Set with ENFit Connector Endovive™M Button Decompression Tube with ENFit Connector Common Name: Gastrointestinal tube and accessories Product Code: PIF Device Class and panel: Class II, Gastroenterology and Urology 21 CFR 876.5980 Classification Regulation:
| 3. Predicate Devices | ||||
|---|---|---|---|---|
| Trade Name: | One Step | |||
| Button, Low | ||||
| Profile Initial | ||||
| Placement PEG | ||||
| Kit | Low Profile | |||
| Button | ||||
| Replacement | ||||
| Gastrostomy | ||||
| Tube Kit | Button Right | |||
| Angle Feeding | ||||
| Set | Button Bolus | |||
| Feeding Set | ||||
| Manufacturer | ||||
| and Clearance | ||||
| Number: | Boston | |||
| Scientific | ||||
| Corporation | ||||
| K910584 | Boston | |||
| Scientific | ||||
| Corporation | ||||
| K014297 | Boston | |||
| Scientific | ||||
| Corporation | ||||
| K014297 | Boston | |||
| Scientific | ||||
| Corporation | ||||
| K014297 |
| KNT
3
Product Code:
Classification Name:
Device Class and panel:
Classification Regulation
KGC
| KNT
21 CFR 876.5980
KNT
Gastrointestinal tube and accessories
Class II, Gastroenterology/Urology
5
4. Device Description
The purpose of this Traditional 510(k) is to demonstrate that the proposed changes to the Y-Port and Bolus/Decompression accessories that are included in the devices identified above do not raise new questions of safety or effectiveness and that the devices are substantially equivalent to the currently marketed EndoVive™ Button kit and Accessory products.
The Y-Port and Bolus/Decompression accessories that are included in the devices identified above have two connections. One is located the distal end and the other is at the proximal end. The connector on the proximal end is identical in design to the ENFit threaded connector of the Y-Port accessory which was cleared via K150679. The Y-Port and Bolus/Decompression accessories are also identical in materials to the Y-Port device which was cleared via K150679. All of the performance and biocompatibility testing that was presented in K150679 to support the ENFit threaded connector is applicable to the Y-Port and Bolus/Decompression accessories of the proposed device. The scope of this submission is to demonstrate that the changes to the distal end of the Y-Port and Bolus/Decompression accessories are substantially equivalent to the predicate device. Neither the Button feeding tube nor the accessories used for tube placement within these kits is changing. The Button feeding tube and placement accessories in the kits are identical to the predicates.
5. Indication for Use:
Endo Vive™ One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector The One Step Button Device is intended to provide nutrition to a patient directly into the stomach through a stoma. It is indicated for use on patients who are unable to consume nutrition by conventional means.
Endovive™ Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector The EndoVive Low Profile Replacement Button Gastrostomy Device is intended to provide nutrition to a patient directly into the stomach through a stoma. It is indicated for use on patients who are unable to consume nutrition by conventional means.
Endovive™ Button Right Angle Feeding Set with ENFit Connector The Right Angle Feeding Set is intended to provide nutrition to a patient directly into the stomach through a gastrostomy tube. It is indicated for use on patients who are unable to consume nutrition by conventional means.
Endovive™ Button Bolus Feeding Set with ENFit Connector
The Bolus Feeding Set is intended to provide nutrition to a patient directly into the stomach through a gastrostomy tube. It is indicated for use on patients who are unable to consume nutrition by conventional means.
Endovive™M Button Decompression Tube with ENFit Connector The Right Angle Decompression Tube is intended to provide stomach decompression through a gastrostomy tube. It is indicated for use on patients who require enteral feeding as a means of nutritional support
6
6. Technological Characteristics:
The Y-Port and Bolus/Decompression accessories included in the initial placement kits, the replacement kits, and replacement accessory sets are the subject of this submission.
The initial placement kit contains a feeding tube that is placed via a procedure called Percutaneous Endoscopic Gastrostomy (PEG). It also contains accessories assembled for the preference of the physician placing the Button feeding set accessories included in the kit are for use in connecting the feeding tube to nutrition.
The replacement kit contains a feeding tube that is used to replace an existing feeding tube using the accessories assembled in the kit. The feeding set accessories included in the kit are for use in connecting the feeding tube to nutrition.
The feeding set and decompression tube accessories that are included in the kits are also sold separately. The Y-Port and Bolus/Decompression accessory within the feeding and decompression tube sets is being modified to comply with the new AAMI/CN3 ISO/DIS 80369-3.2 standard requirements to reduce the risk of misconnection with non-enteral feeding devices. The AAMI/CN3 ISO/DIS 80369-3.2 ENFit thread design will be added to the connector and the connector will be made of a more rigid material. Other than the connector changes, the Button feeding tube and placement accessories in the kits are identical to the predicates.
7. Performance Data:
The Endo Vive™ Button Kit with ENFit and Accessories have been tested according to the following standards:
- AAMI CN3:2014 (PS)/ ISO/DIS 80369-3.2 Small bore connectors for liquids and . gases in healthcare applications - Part 3: Connectors for enteral applications
- . AAMI CN20:2014 (PS)/ ISO 80369-20 gases in healthcare applications - Part 20: Common test methods
The information presented in this submission to support substantial equivalence of the Endo Vive Button Kit with ENFit and Accessory with ENFit Connector to the legally marketed predicate devices include: device description, indications for use, device comparison, material information, and labeling. Bench testing of the connector ISO/DIS 80369-3.2 ENFit thread design supports compliance to the material, and non-interconnectability, principles of the ISO 80369-1: 2010 standard. This performance assessment includes Risk analysis, Enteral Connector Misconnection Assessment, Enteral Connector Risk Management Report, Human Factors Validation Study, and ENFit Misconnection data with FMEA, tensile strength, flow rate, and liquid leakage.
Boston Scientific has assessed the similarities between the proposed Endo Vive Button Kit with ENFit and Accessories with ENFit Connector and its predicates in terms of intended use and technological characteristics. The differences in the technological characteristics are
7
minor and do not present any new issues of safety or effectiveness. This evidence supports a finding of substantial equivalence between the products.
8. Conclusion:
Boston Scientific Corporation has demonstrated that the proposed Endo Vive Button Kit with ENFit Connector and Accessories with ENFit Connector are substantially equivalent to the currently marketed EndoVive Initial Placement Button Kit (K910584), EndoVive Replacement Button Kit (K014297) and Decompression Tube (K920894).