(159 days)
Not Found
No
The device description and performance studies focus on mechanical and magnetic components and their interaction, with ultrasound used for visualization by the user. There is no mention of automated analysis, image processing, or any AI/ML terms.
No.
The device facilitates the placement of a feeding tube but does not directly treat a disease or condition. It is an aid for a procedure, not a therapeutic intervention itself.
No
The device is designed to facilitate the placement of a gastrostomy feeding tube by affixing the stomach to the anterior abdominal wall, providing visualization by ultrasound to assess the future gastrostomy tract. While it uses ultrasound for visualization, its primary function is to aid in a procedural step (tube placement), not to diagnose a condition or disease.
No
The device description explicitly details multiple physical components (balloon catheter, guidewire, external magnet) and describes their physical interaction and use in a procedure. It is not solely software.
Based on the provided information, the CoapTech PUMA-G System 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.
- PUMA-G System Function: The PUMA-G System is a medical device used during a surgical procedure (percutaneous gastrostomy) to physically manipulate and secure anatomical structures (stomach and abdominal wall) and facilitate the placement of a feeding tube. It uses ultrasound for visualization during the procedure, not to analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "affixing the stomach to the anterior abdominal wall facilitating the initial percutaneous placement of a gastrostomy feeding tube." This is a procedural aid, not a diagnostic test performed on a sample.
The device description and intended use clearly indicate that the PUMA-G System is a tool used in vivo (within the living body) to assist in a medical procedure, not a test performed in vitro (outside the living body) on a biological sample.
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 only.
Product codes (comma separated list FDA assigned to the subject device)
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 over the guidewire using the Sachs-Vine PUSH 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 only
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 and animal 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. 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): 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 10. 2019
CoapTech, LLC Jack Kent, MBA, MPH Chief Commercialization Officer 8 Market Pl., Suite 804 Baltimore, MD 21202
Re: K183057 Trade/Device Name: PUMA-G System Regulation Number: 21 CFR$ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: KGC Dated: March 4, 2019 Received: March 13, 2019
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 (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. 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 legally 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/tray. 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.
1
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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark J. Antonino -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183057
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 only.
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)
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Image /page/3/Picture/0 description: The image shows the logo for COAPTECH. The logo consists of a stylized symbol above the word "COAPTECH". The symbol is made up of two interlocking shapes that resemble magnets, with green squares at the ends. The word "COAPTECH" is written in a bold, sans-serif font in a dark blue color.
510(k) Summary
(per 21 CFR 807.92)
Submitter Information
| Name | CoapTech LLC |
|---|---|
| Address | 8 Market Pl., Suite 804 |
| Baltimore, MD 21202 | |
| Phone Number | (443) 574-6981 |
| Contact Person | Jack Kent, MBA MPH |
| Chief Commercialization Officer | |
| Date Prepared | April 8, 2019 |
Device Information
| Trade Name | PUMA-G System |
|---|---|
| Common Name | Feeding Tube Placement Aid |
| Classification | Gastrointestinal tube and accessories |
| 21 CFR 876.5980 (Product Code KGC) |
Predicate Device Information
| Device Name | Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy™ T-Fastener |
|---|---|
| K Number | K093312 |
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 over the guidewire using the Sachs-Vine PUSH technique.
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Image /page/4/Picture/1 description: The image shows the logo for COAPTECH. The logo features two interlocking blue shapes that resemble magnets. The ends of the magnets are capped with green squares. Below the interlocking shapes, the word "COAPTECH" is written in blue, sans-serif font.
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 only.
Technological Characteristics
As shown in Table 1, many technological similarities exist between the subject and predicate devices. The type of force utilized in the PUMA-G System is magnetic – versus tension used with gastropexy anchors – and therefore, 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).
Table 1: Comparison of Technological Characteristics
| Characteristic | Subject Device
PUMA-G System | Predicate Device (K093312)
Safe-T-Pexy | Comparison |
|-------------------------|-----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Mechanism (General) | Mechanical (affix stomach to
anterior abdominal wall) | Mechanical (affix stomach to
anterior abdominal wall) | Same |
| Mechanism (Detail) | Magnetic Attraction | Anchoring | Equivalent |
| Time |