(274 days)
Not Found
No.
The device description focuses on mechanical and physical components (balloon catheter, guidewire, magnets) and its function in facilitating percutaneous gastrostomy via ultrasound visualization, without any mention of AI, machine learning, or deep learning components. The performance studies describe bench and clinical tests related to the physical integrity and function of the device, not the performance of any AI model.
Yes
Explanation: The device is intended to facilitate the initial percutaneous placement of a gastrostomy feeding tube by affixing the stomach to the anterior abdominal wall. This is a medical intervention aimed at treating or managing a condition, specifically for patients requiring a gastrostomy tube.
No
The device is intended to aid in the initial placement of gastrostomy feeding tubes by facilitating the securement of the stomach to the abdominal wall and providing ultrasound-guided visualization for needle placement. Its primary function is procedural assistance rather than diagnosing a disease or condition.
No
The device is a hardware system composed of a balloon catheter, guidewire, and external magnet, designed to physically manipulate anatomical structures for gastrostomy tube placement. It explicitly describes physical components and their mechanical actions. While it uses ultrasound for visualization, the device itself is not software.
No.
The device is a medical device for facilitating the placement of a gastrostomy feeding tube and does not involve in vitro examination of human body specimens.
N/A
Intended Use / Indications for Use
The CoapTech PUMA-G Pediatric System is intended to affix the stomach to the anterior abdominal wall facilitating the initial percutaneous placement of a gastrostomy feeding tube. The PUMA-G Pediatric System is intended to be utilized in pediatric patients that meet criteria for minimum weight (15 kg) and appropriate abdominal wall thickness (between 0.6 cm and 3.0 cm), as stated in the instructions for use.
Product codes
KGC
Device Description
The PUMA-G Pediatric System is a medical device designed to aid in the initial placement of permanent feeding tubes, which are placed via percutaneous gastrostomy. Historically, gastrostomy tubes have been placed using either endoscopy or radiography (e.g., fluoroscopy) for visualization. The PUMA-G Pediatric System provides visualization by ultrasound, allowing the user to assess the future gastrostomy tract prior to placement. The PUMA-G Pediatric System contains three main custom components: a balloon catheter, a guidewire, and an external magnet. An internal magnet within the balloon catheter is placed orogastrically into the stomach, where it is pulled up to the anterior abdominal wall by the external magnet. After filling the balloon with fluid, the user's existing ultrasound is used for visualization of the future gastrostomy tract and for ultrasound-guided needle placement. The guidewire is then inserted and snared by the balloon, and the paired unit (balloon catheter and guidewire) is then pulled out the mouth. A gastrostomy tube is then placed over the guidewire using either the Sachs-Vine PUSH technique or the Ponsky PULL technique.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Stomach, anterior abdominal wall
Indicated Patient Age Range
Pediatric patients that meet criteria for minimum weight (15 kg) and appropriate abdominal wall thickness (between 0.6 cm and 3.0 cm).
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
Bench and clinical performance data were collected to support a substantial equivalence determination. This testing included balloon performance per ASTM F2528-06, magnetic force characterization (force evaluation and tissue response), coupling strength information, capture reliability, biocompatibility, and sterilization.
A small safety clinical study was also done, yielding favorable results. This single-center study utilized the PUMA-G Pediatric System on pediatric patients indicated for gastrostomy tube. All patients successfully completed the gastrostomy procedure with no serious adverse events or device-related adverse events. Data was compared to a historical control. The primary endpoint of safely completing the gastrostomy procedure was met. Secondary endpoints also showed a reduction in radiation exposure compared to fluoroscopy-based gastrostomy (historical control). This study did not support use of the PUMA-G Pediatric System in patients under 15 kg or outside the acceptable abdominal wall thickness range (0.6 cm to 3.0 cm), due to low (or lack of) enrollment in these demographics.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
FDA 510(k) Clearance Letter - PUMA-G Pediatric System
Page 1
April 29, 2025
CoapTech Inc.
Jack Kent
Chief Commercialization Officer
101 W. Dickman St.
Suite 700
Baltimore, Maryland 21230
Re: K242211
Trade/Device Name: PUMA-G Pediatric System
Regulation Number: 21 CFR 876.5980
Regulation Name: Gastrointestinal Tube and Accessories
Regulatory Class: Class II
Product Code: KGC
Dated: July 26, 2024
Received: July 29, 2024
Dear Jack Kent:
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) 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Page 2
K242211 - Jack Kent Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
Page 3
K242211 - Jack Kent Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Anthony Lee -S
Anthony C. Lee, Ph.D., M.B.A.
Assistant Director
DHT3A: Division of Renal, Gastrointestinal,
Obesity, and Transplant Devices
OHT3: Office of Gastrorenal, ObGyn,
General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K242211
Device Name
PUMA-G Pediatric System
Indications for Use (Describe)
The CoapTech PUMA-G Pediatric System is intended to affix the stomach to the anterior abdominal wall facilitating the initial percutaneous placement of a gastrostomy feeding tube. The PUMA-G Pediatric System is intended to be utilized in pediatric patients that meet criteria for minimum weight (15 kg) and appropriate abdominal wall thickness (between 0.6 cm and 3.0 cm), as stated in the instructions for use.
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Page 5
Page 1 of 3
PUMA-G Pediatric System – 510(k) Summary
510(k) Summary
(per 21 CFR 807.92)
Submitter Information
| Field | Information |
|---|---|
| Name | CoapTech Inc. |
| Address | 101 W. Dickman St, Suite 700 |
| Baltimore, MD 21230 | |
| Phone Number | (443) 574-6981 |
| Contact Person | Jack Kent, MBA MPH |
| Chief Commercialization Officer | |
| Date Prepared | April 28, 2025 |
Device Information
| Field | Information |
|---|---|
| Trade Name | PUMA-G Pediatric System |
| Common Name | Feeding Tube Placement Aid |
| Classification | Gastrointestinal tube and accessories |
| Regulation Number | 21 CFR 876.5980 |
| Product Code | KGC |
| Regulatory Class | II |
Predicate Device Information
| Field | Information |
|---|---|
| Device Name | PUMA-G System |
| K Number | K223916 |
Device Description
The PUMA-G Pediatric System is a medical device designed to aid in the initial placement of permanent feeding tubes, which are placed via percutaneous gastrostomy. Historically, gastrostomy tubes have been placed using either endoscopy or radiography (e.g., fluoroscopy) for visualization. The PUMA-G Pediatric System provides visualization by ultrasound, allowing the user to assess the future gastrostomy tract prior to placement. The PUMA-G Pediatric System contains three main custom components: a balloon catheter, a guidewire, and an external magnet. An internal magnet within the balloon catheter is placed orogastrically into the stomach, where it is pulled up to the anterior abdominal wall by the external magnet. After filling the balloon with fluid, the user's existing ultrasound is used for visualization of the future gastrostomy tract and for ultrasound-guided needle placement. The guidewire is then inserted and snared by the balloon, and the paired unit (balloon catheter and guidewire) is then pulled out the mouth. A gastrostomy tube is then placed over the guidewire using either the Sachs-Vine PUSH technique or the Ponsky PULL technique.
Page 6
Page 2 of 3
Intended Use
To Aid in Percutaneous Access to the Stomach During Gastrostomy Tube Placement.
Indications for Use
The CoapTech PUMA-G Pediatric System is intended to affix the stomach to the anterior abdominal wall facilitating the initial percutaneous placement of a gastrostomy feeding tube. The PUMA-G Pediatric System is intended to be utilized in pediatric patients that meet criteria for minimum weight (15 kg) and appropriate abdominal wall thickness (between 0.6 cm and 3.0 cm), as stated in the instructions for use.
Comparison to Predicate
The PUMA-G System indications for use statement is equivalent to the predicate device. Additional conditions for use (weight and abdominal wall thickness) have been added to specify use within the pediatric population.
Technological Characteristics
As shown in Table 1, many technological similarities exist between the subject and predicate device. Other differences in technological characteristics are minor and/or common to other gastrostomy tube placement devices (e.g., endoscopy).
Table 1: Comparison of Technological Characteristics
| Characteristic | Subject Device
PUMA-G Pediatric System | Predicate Device (K223916)
PUMA-G System | Comparison |
|----------------|-------------------------------------------|---------------------------------------------|------------|
| Mechanism (General) | Mechanical (affix stomach to anterior abdominal wall) | Mechanical (affix stomach to anterior abdominal wall) | Same |
| Mechanism (Detail) | Magnetic Attraction | Magnetic Attraction | Same |
| Coaptation Time |