(42 days)
Not Found
No
The summary describes a medical device kit for enteral feeding and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The devices are indicated for providing enteral nutrition directly into the stomach or jejunum for patients unable to consume nutrition by conventional means, which is a therapeutic purpose.
No
The device is used for enteral nutrition, meaning it delivers nutrition directly into the stomach or jejunum. Its purpose is to provide nutrition, not to diagnose a medical condition.
No
The device description clearly indicates these are "kits" used for "initial placement for direct feeding," implying physical components like tubes, needles, or other instruments, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for enteral nutrition directly into the stomach or jejunum. This is a therapeutic intervention for providing nutrition, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the use of the kits for direct feeding.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze samples (like blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition. The device is used to deliver something into the body.
IVD devices are used to perform tests in vitro (outside the body) on biological samples to diagnose, monitor, or screen for diseases or conditions. This device is used in vivo (inside the body) for nutritional support.
N/A
Intended Use / Indications for Use
EndoVive™ Initial Placement PEG Kit is indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means.
The EndoVive™ Initial Placement Direct PEJ Kit is indicated for use for enteral nutritional support and decompression directly into the jejunum when feeding via the upper gastrointestinal tract is contraindicated.
The EndoVive™ Initial Placement PEG Safety Kit is indicated for providing nutrition directly into the stomach in patients who are unable to consume nutrition by conventional means. The safety components of the kit are designed to reduce the potential for inadvertent sharps injury to medical personnel during and after the procedure.
Product codes (comma separated list FDA assigned to the subject device)
78 KNT
Device Description
The proposed EndoVive™ Initial Placement PEG Kit, the proposed EndoVive™ Initial Placement Direct PEJ Kit, and the EndoVive™ Initial Placement PEG Safety Kit are used during initial placement for direct feeding.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Stomach, Jejunum
Indicated Patient Age Range
pediatric and adult patients
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 substantially equivalent to currently marketed devices in terms of performance characteristics and were tested for biocompatibility.
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.
0
Special 510(k) Premarket Notification New Size and New Transition Design
K031538
l of 2
Boston Scientific Corporation
May 15, 2003
JUN 2 7 2003
510(K) SUMMARY
Boston Scientific Corporation (BSC) SPONSOR: Microvasive Endoscopy Division One Boston Scientific Place Natick, MA 01760 Paige Sweeney CONTACT/SUBMITTER: Senior Regulatory Affairs Specialist DATE OF SUBMISSION: May 14, 2003 EndoVive™ Initial Placement PEG Kit EndoVive™ DEVICES: Initial Placement Direct PEJ Kit EndoVive™ Initial Placement PEG Safety Kit EndoVive™ Initial Placement PEG Kit TRADE NAME: COMMON NAME: Gastrostomy Tube CLASSIFICATION: Tubes, Gastrointestinal & Accessories Tube, Gastro-Enterostomy Classified Under 21 CFR Part 876, §5980. Classified as a Class II Device EndoVive™ Initial Placement Direct PEJ Kit TRADE NAME: COMMON NAME: Jejunostomy Tube CLASSIFICATION: Tube, Feeding Classified Under 21 CFR Part 876, §5980. Classified as a Class II Device EndoVive™ Initial Placement PEG Safety Kit TRADE NAME: COMMON NAME: Gastrostomy Tube CLASSIFICATION: Tubes, Gastrointestinal & Accessories Tube, Gastro-Enterostomy Classified Under 21 CFR Part 876, §5980. Classified as a Class II Device EndoVive™ Initial Placement PEG Kit PREDICATE DEVICES: (K030855) EndoVive™ Initial Placement Direct PEJ Kit (K030855) EndoVive™ Initial Placement PEG Safety Kit (K030852) DEVICE DESCRIPTIONS: The proposed EndoVive™ Initial Placement PEG Kit, the proposed EndoVive™ Initial Placement Direct PEJ Kit, and the EndoVive™ Initial Placement
1
INTENDED USES:
PEG Safety Kit are used during initial placement for direct feeding.
EndoVive™ Initial Placement PEG Kit is indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means.
The EndoVive™ Initial Placement Direct PEJ Kit is indicated for use for enteral nutritional support and decompression directly into the jejunum when feeding via the upper gastrointestinal tract is contraindicated.
The EndoVive™ Initial Placement PEG Safety Kit is indicated for providing nutrition directly into the stomach in patients who are unable to consume nutrition by conventional means. The safety components of the kit are designed to reduce the potential for inadvertent sharps injury to medical personnel during and after the procedure.
COMPARISON OF CHARACTERISTICS:
PERFORMANCE DATA:
the exception of the proposed domed PEG/PEJ material.
The proposed devices are substantially equivalent to
currently marketed devices, as they are identical with
The proposed devices are substantially equivalent to currently marketed devices in terms of performance characteristics and were tested for biocompatibility.
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem that appears to be an abstract representation of an eagle or bird with three lines forming its body and wings.
Public Health Service
JUN 2 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Paige Sweeney Senior Regulatory Affairs Specialist Boston Scientific Corporation One Boston Scientific Place NATICK MA 01760
Re: K031538 Trade Name: EndoVive™ Initial Placement PEG Kit, Direct PEJ Kit, and PEG Safety Kit Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: 78 KNT Dated: May 15, 2003 Received: May 30, 2003
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 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
3
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); 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 kit contains antibiotic ointment, iodine swabs and 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, please contact the Office of Compliance at (301) 594-4616. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrh.dsma/dsmamain.html.
Sincerely yours,
David C. Brogdon
Nancy C. Brogdon
for
Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
INDICATIONS FOR USE STATEMENTS
| 510(k) Number
| (if known) | To be determined | Page 1 of 1 |
|---|---|---|
| Device Names | EndoVive™ Initial Placement PEG Kit | |
| EndoVive™ Initial Placement Direct PEJ Kit | ||
| EndoVive™ Initial Placement PEG Safety Kit | ||
| Indications for Use | EndoVive™ Initial Placement PEG Kit is indicated for enteral | |
| nutrition directly into the stomach in both pediatric and adult patients | ||
| who are unable to consume nutrition by conventional means. | ||
| The EndoVive™ Initial Placement Direct PEJ Kit is indicated for | ||
| nutritional support and decompression directly into the jejunum when | ||
| feeding via the upper gastrointestinal tract is contraindicated. | ||
| The EndoVive™ Initial Placement PEG Safety Kit is indicated for | ||
| providing nutrition directly into the stomach in patients who are | ||
| unable to consume nutrition by conventional means. The safety | ||
| components of the kit are designed to reduce the potential for | ||
| inadvertent sharps injury to medical personnel during and after the | ||
| procedure. |
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED ﮯ
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over the Counter Use _________________________________________________________________________________________________________________________________________________________
Orrin A. Ingram
(Division Sign-Off) Division of Reproductive, Abd and Radiological Devi 510(k) Number
な
Proprietary and Confidential Information of Boston Scientific Corporation
00000