(190 days)
Not Found
Not Found
No
The summary describes a gastrostomy tube kit for feeding, with no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies. The performance studies section also indicates the device is identical to predicates, further suggesting no novel AI/ML components.
Yes
The device is used to provide nutrition directly to the stomach for patients unable to consume nutrition conventionally, which addresses a medical condition and supports the patient's health.
No
The devices described are gastrostomy kits and tubes used to provide nutrition directly to the stomach. Their purpose is therapeutic (feeding), not diagnostic (identifying conditions or diseases).
No
The device description clearly indicates that these are physical gastrostomy kits and tubes, which are hardware devices, not software.
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 for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that these devices are used to provide nutrition directly into the stomach. They are tubes and kits for feeding, not for analyzing biological samples.
- Intended Use: The intended use is for providing nutrition, not for diagnosing a condition or analyzing a biological sample.
Therefore, based on the provided information, these devices fall under the category of medical devices used for direct patient care and treatment (feeding), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Endovive™ Initial Placement Gastrostomy Kits (Guidewire & Pull) and the Securi-TTM Initial Placement Gastrostomy (Guidewire & Pull) are indicated to provide nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means.
The Endovive™ Low Profile Button Replacement Gastrostomy Device is indicated to provide nutrition directly into the stomach through the stoma. It is indicated for use in adult and pediatric patients who are unable to consume nutrition by conventional means.
Product codes (comma separated list FDA assigned to the subject device)
78 KNT, 78 KGC
Device Description
The Endovive™ Initial Placement Gastrostomy Kit and the Securi-T™ Initial Placement Gastrostomy Kits are used during initial placement for direct feeding, and the Endovive™ Low Profile Button Replacement Gastrostomy Tube is used for the replacement of direct feeding tubes used for direct feeding.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Stomach
Indicated Patient Age Range
Adult and pediatric populations
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 proposed devices are identical to the predicate devices and therefore, no additional performance testing was performed.
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.
Not Found
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.
0
Koi4297 page lot 3
วันเ 9 2002
SECTION 14 510(K) SUMMARY
FOI RELEASABLE
Pursuant to §513(1)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification "…adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation chooses to submit a summary of information respecting safety and effectiveness.
| Date: | December 28, 2001 | ||
|---|---|---|---|
| Common/Usual Names: | Tube, Gastrointestinal | ||
| Tube, Gastro-Enterostomy | |||
| Trade/Proprietary Names: | - Endovive™ Initial Placement | ||
| Gastrostomy Kit |
- Securi-T Initial Placement
Gastrostomy Kit - Endovive™ Low Profile Button Replacement
Gastrostomy Tube | | |
| Classification Name &
Device Classification: | Class II | | |
| | Name | Number | 21CFR Ref. |
| | Tubes,
Gastroint. & Acc. | 78 KNT | 876.5980 |
| | Tube,
Gastro-Enterostomy | 78 KGC | 876.5980 |
| Device Panel/Branch: | Gastroenterology-Urology (GU)
Gastro-Renal (GRDB) | | |
| Owner/Operator: | Boston Scientific Corporation
One Boston Scientific Place
Natick, MA 01760 | | |
| Contact Person: | Paige Sweeney
Regulatory Affairs Specialist | | |
Proprietary and Confidential Information of Boston Scientific Corporation
1
Description of Devices
The Endovive™ Initial Placement Gastrostomy Kit and the Securi-T™ Initial Placement Gastrostomy Kits are used during initial placement for direct feeding, and the Endovive™ Low Profile Button Replacement Gastrostomy Tube is used for the replacement of direct feeding tubes used for direct feeding.
Indications for Use
The Endovive™ Initial Placement Gastrostomy Kits (Guidewire & Pull) and the Securi-TTM Initial Placement Gastrostomy (Guidewire & Pull) are indicated to provide nutrition directly into the stomach in adult and pediatric patients who are unable to consume nutrition by conventional means.
The Endovive™ Low Profile Button Replacement Gastrostomy Device is indicated to provide nutrition directly into the stomach through the stoma. It is indicated for use in adult and pediatric patients who are unable to consume nutrition by conventional means.
Descriptive and Technological Characteristics of Proposed and Predicate Devices
Boston Scientific Corporation believes that the Endovive™ Initial Placement Gastrostomy Kit, the Securi-T™ Initial Placement Gastrostomy Kit, and the Endovive™ Low Profile Button Replacement Gastrostomy Device, are substantially equivalent to the currently marketed Endovive™ Initial Placement Gastrostomy Kit, the Securi-T™ Initial Placement Gastrostomy Kit , and the Endovive™ Low Profile Button Replacement Gastrostomy Device, and the Endovive™ Low Profile Initial Placement Gastrostomy Kit. The major components of these devices are the internal bolster and the gastrostomy tube. A thorough comparison of the descriptive characteristics between the proposed gastrostomy devices and the predicate devices show equivalence.
2
Performance Characteristics
The proposed devices are identical to the predicate devices and therefore, no additional performance testing was performed.
Conclusion
Boston Scientific Corporation has demonstrated that the Endovive™ Initial Placement Gastrostomy Kit, the Securi-TTM Initial Placement Gastrostomy Kit, and the Endovive™ Low Profile Button Replacement Gastrostomy Tube are substantially equivalent to the currently marketed Endovive™ Initial Placement Gastrostomy Kit, the Securi-T™ Initial Placement Gastrostomy Kit, the Endovive™ Low Profile Button Replacement Gastrostomy Tube, and the Endovive™ Low Profile Initial Placement Gastrostomy Kit.
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of a stylized eagle with three human profiles incorporated into its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
9 2002 JUL
Ms. Paige Sweeney Regulatory Affairs Specialist Microvasive Endoscopy Boston Scientific Corporation One Boston Scientific Place NATICK MA 01760-1537
Re: K014297
Trade/Device Name: Endovive™ Initial Placement Gastrostomy Kit Endovive™ Low Profile Button Replacement Gastrostomy Tube (Button™) Securi-TTM Initial Placement Gastrostomy Kit Regulation Number: 21 CFR 876.5980
Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: 78 KNT Dated: April 9, 2002 Received: April 10, 2002
Dear Ms. Sweeney:
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 (the Act). You may, therefore, market the device, subject to the general controls provisions of Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were 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. 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.
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
4
Page 2 - Ms. Paige Sweeney
the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good 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.
In addition, we have determined that your device kit contains iodine swabs, lubricating jelly, antibiotic ointment, and 1% Xylocaine, 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:
Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0101
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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR Part 807.97). Other general information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its Internet address http://www.fda.gov/dsma/dsmamain.html
Sincerely yours.
David C. Bergman
Nancy C. Brogdon Director Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
KO14644
SECTION 3 INDICATIONS FOR USE
| 510(k) Number: | To Be Determined |
|---|---|
| ---------------- | ------------------ |
- Endovive™ Initial Placement Gastrostomy Kit Device Names: -Endovive™ Low Profile Replacement Gastrostomy Tube -Securi-TTM Initial Placement Gastrostomy Kit -
Indications for Use: The Endovive™ Initial Placement Gastrostomy Kits (Guidewire & Pull) and the Securi-T™Initial Placement Gastrostomy Kits (Guidewire & Pull) are indicated for adult and pediatric populations to provide nutrition directly into the stomach in patients who are unable to consume nutrition by conventional means.
The Endovive™ Low Profile Button Replacement Gastrostomy Tube is indicated in adult and pediatric populations to provide nutrition directly into the stomach through an existing stoma. They are indicated for use on patients who are unable to consume nutrition by conventional means.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Prescription Use | OR | Over-The-Counter Use | |
|---|---|---|---|
| (Per 21CFR 801.1091) | (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
Proprietary and Confidential Information of Boston Scientific Corporation