(30 days)
Not Found
No
The summary describes a kit for enteral feeding tube placement and does not mention any computational or analytical capabilities that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes.
These devices are indicated for providing enteral nutrition to patients who are unable to consume nutrition by conventional means, which is a therapeutic intervention.
No
The device descriptions and indications for use state that these devices are used for enteral nutrition. There is no mention of diagnosing conditions or diseases.
No
The device description clearly indicates these are physical kits used for enteral feeding, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that these devices are used for enteral nutrition directly into the stomach or jejunum. This is a method of delivering food and nutrients directly into the digestive system, bypassing the mouth and esophagus.
- Lack of Diagnostic Activity: There is no mention of the device analyzing samples, detecting biomarkers, or providing diagnostic information. Its purpose is purely for delivering nutrition.
Therefore, these devices fall under the category of medical devices used for therapeutic purposes (providing nutrition), not for in vitro diagnostic testing.
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
K030855
1 of 2
Special 510(k) Premarket Notification New Material for Domed PEG/PEJ
Boston Scientific Corporation March 17, 2003
APR 1 7 2003
510(K) SUMMARY
| SPONSOR: | Boston Scientific Corporation (BSC)
Microvasive Endoscopy Division
One Boston Scientific Place
Natick, MA 01760 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT/SUBMITTER: | Paige Sweeney
Senior Regulatory Affairs Specialist |
| DATE OF SUBMISSION: | March 17, 2003 |
| DEVICES: | EndoVive ™ Initial Placement PEG Kit EndoVive ™
Initial Placement Direct PEJ Kit
EndoVive ™ Initial Placement PEG Safety Kit |
| TRADE NAME: | EndoVive ™ Initial Placement PEG Kit |
| COMMON NAME: | Gastrostomy Tube |
| CLASSIFICATION: | Tubes, Gastrointestinal & Accessories
Tube, Gastro-Enterostomy
Classified Under 21 CFR Part 876, §5980.
Classified as a Class II Device |
| TRADE NAME: | EndoVive ™ Initial Placement Direct PEJ Kit |
| COMMON NAME: | Jejunostomy Tube |
| CLASSIFICATION: | Tube, Feeding
Classified Under 21 CFR Part 876, §5980.
Classified as a Class II Device |
| TRADE NAME: | EndoVive ™ Initial Placement PEG Safety Kit |
| COMMON NAME: | Gastrostomy Tube |
| CLASSIFICATION: | Tubes, Gastrointestinal & Accessories
Tube, Gastro-Enterostomy
Classified Under 21 CFR Part 876, §5980.
Classified as a Class II Device |
| PREDICATE DEVICES: | EndoVive ™ Initial Placement PEG Kit
(K014297)
EndoVive ™ Initial Placement Direct PEJ Kit
(K020120)
EndoVive ™ Initial Placement PEG Safety Kit
(K014297) |
| DEVICE DESCRIPTIONS: | The proposed EndoVive ™ Initial Placement PEG
Kit, the proposed EndoVive ™ Initial Placement
Direct PEJ Kit, and the EndoVive ™ Initial Placement |
1
K030855
2 of 2
ﻳﻨ
INTENDED USES:
COMPARISON OF
CHARACTERISTICS:
Boston Scientific Corporation March 17, 2003
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.
The proposed devices are substantially equivalent to currently marketed devices, as they are identical with the exception of the proposed domed PEG/PEJ material.
The proposed devices are substantially equivalent to PERFORMANCE DATA: currently marketed devices in terms of performance characteristics and were tested for biocompatibility.
2
Image /page/2/Picture/12 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles a human figure or a bird in flight, composed of several curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 7 2003
Ms. Paige Sweeney Senior Regulatory Affairs Specialist Boston Scientific Corporation Microvasive Endoscopy One Boston Scientific Place NATICK MA 01760
Re: K030855
Trade/Device Name: EndoVive™ Initial Placement PEG Kit EndoVive™ Initial Placement Direct PEJ Kit EndoVive™ Initial Placement PEG Safety Kit Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: 78 KNT Dated: March 17, 2003 Received: March 18, 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 (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
3
Page 2 - Ms. Paige Sweeney
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 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 component[s] 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- . 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/dsma/dsmamain.html.
Sincerely yours.
David A. Segner
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KO 30855
Special 510(k) Premarket Notification New Material for Domed PEG/PEJ
Boston Scientific Corporation March 17, 2003
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 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------~ = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over the Counter Use _________________________________________________________________________________________________________________________________________________________
David R. Lehman
(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 510(k) Number
000101
Proprietary and Confidential Information of Boston Scientific Corporation