(90 days)
No
The device description focuses on mechanical components (balloon catheter, guidewire, magnets) and utilizes existing ultrasound for visualization. There is no mention of AI/ML in the device description, intended use, or performance studies.
No
The device is intended to facilitate the placement of a gastrostomy feeding tube, not to directly treat a disease or condition. Its function is primarily to aid in a medical procedure.
No
The PUMA-G System is an interventional device designed to facilitate the placement of a gastrostomy feeding tube. While it uses ultrasound for visualization and assessment of the gastrostomy tract, its primary function is to aid in the procedure itself, not to diagnose a condition.
No
The device description explicitly lists three main custom hardware components: a balloon catheter, a guidewire, and an external magnet. While it utilizes existing ultrasound for visualization, the core system involves physical components for affixing the stomach and facilitating guidewire placement.
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 CoapTech PUMA-G System is a medical device used during a surgical procedure (percutaneous gastrostomy) to facilitate the placement of a feeding tube. It uses physical components (balloon catheter, guidewire, magnets) and ultrasound imaging to guide the procedure.
- No Sample Analysis: The device does not analyze any samples taken from the patient's body. It is used to manipulate and visualize anatomical structures within the body.
Therefore, the PUMA-G System falls under the category of a surgical or procedural device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The CoapTech PUMA-G System (PUMA-G) is intended to affix the stomach to the anterior abdominal wall facilitating the initial percutaneous placement of a gastrostomy feeding tube in adults and adolescents of sufficient size ("Transitional Adolescent B" patients 18 to 21 years of age with no special considerations compared to adults).
Product codes
KGC
Device Description
The PUMA-G 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 System provides visualization by ultrasound, allowing the user to assess the future gastrostomy tract prior to placement. The PUMA-G 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 using the guidewire and Seldinger 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
Adults and adolescents of sufficient size ("Transitional Adolescent B" patients 18 to 21 years of age with no special considerations compared to adults).
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)
Bench performance data were collected to support a substantial equivalence determination. This testing included magnetic force characterization and coupling strength information. Performance test results demonstrate reasonable assurance that the PUMA-G System can effectively bring together the stomach and anterior abdominal wall while maintaining healthy tissue. The PUMA-G System also reliably captures and retains the guidewire for eventual completion of the gastrostomy tube placement. These data suggest the PUMA-G System is as safe and as effective as the identified predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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March 29, 2023
CoapTech Inc. Jack Kent Chief Commercialization Officer 101 W. Dickman Street, Suite 700 Baltimore, MD 21230
K223916 Trade/Device Name: PUMA-G System Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: KGC Dated: December 28, 2022 Received: December 29, 2022
Dear Jack Kent:
Re:
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. 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 located 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.
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
1
Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-devices/medical-device-safety/medicaldevice-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-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-advicecomprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sivakami Venkatachalam -S
for
Shanil P. Haugen, Ph.D. 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
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Indications for Use
510(k) Number (if known) K223916
Device Name PUMA-G System
Indications for Use (Describe)
The CoapTech PUMA-G System (PUMA-G) is intended to affix the stomach to the anterior abdominal wall facilitating the initial percutaneous placement of a gastrostomy feeding tube in adults and adolescents of sufficient size ("Transitional Adolescent B" patients 18 to 21 years of age with no special considerations compared to adults).
| 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) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ||
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows a logo for a company called COAPTECH. The logo features the company name in a bold, sans-serif font, with the letters stacked vertically. Above the name is a stylized graphic that resembles two magnets facing each other. The magnets are blue with green ends.
510(k) Summary
(per 21 CFR 807.92)
Submitter Information
| Name | CoapTech Inc. |
|---|---|
| Address | 101 W. Dickman Street, Suite 700 |
| Baltimore, MD 21230 | |
| Phone Number | (443) 574-6981 |
| Contact Person | Jack Kent, MBA MPH |
| Chief Commercialization Officer | |
| Date Prepared | March 18, 2023 |
Device Information
| Trade Name | PUMA-G System |
|---|---|
| Common Name | Gastrostomy Aid |
| Classification | Gastrointestinal tube and accessories |
| 21 CFR 876.5980 (Product Code KGC) |
Predicate Device Information
| Device Name | PUMA-G System |
|---|---|
| K Number | K183057 |
Device Description
The PUMA-G 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 System provides visualization by ultrasound, allowing the user to assess the future gastrostomy tract prior to placement. The PUMA-G 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 using the guidewire and Seldinger technique.
4
Image /page/4/Picture/0 description: The image shows the logo for COAPTECH. The logo features a stylized, interconnected blue design resembling two magnets facing each other, with green squares at the ends. Below the design, the word "COAPTECH" is written in a bold, sans-serif font, also in blue.
Intended Use
To Aid in Percutaneous Access to the Stomach During Gastrostomy Tube Placement
Indications for Use
The CoapTech PUMA-G System (PUMA-G) is intended to affix the stomach to the anterior abdominal wall facilitating the initial percutaneous placement of a gastrostomy feeding tube in adults and adolescents of sufficient size ("Transitional Adolescent B" patients 18 to 21 years of age with no special considerations compared to adults).
Comparison to Predicate
The PUMA-G System indications for use includes adolescents of sufficient size, meaning patients that are similarly sized to adults.
Technological Characteristics
As shown in Table 1, many technological similarities exist between the subject and predicate devices. The magnetic force was characterized in performance testing to ensure it can adequately create temporary affixture of the tissue (effectiveness) without harming the tissue (safety). Other differences in technological characteristics are minor and/or common to other gastrostomy tube placement devices (e.g., endoscopy).
| Characteristic | Subject Device
PUMA-G System | Predicate Device (K183057)
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 |
| Time |