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).

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.

AI/ML Overview

The provided text describes the PUMA-G System, a medical device intended to affix the stomach to the anterior abdominal wall to facilitate the initial percutaneous placement of a gastrostomy feeding tube.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria in a formal table or list. However, the "Performance Data" section describes the types of performance data collected and the conclusions drawn regarding effectiveness and safety.

Acceptance Criteria Category (Derived)	Desired Outcome (Derived)	Reported Device Performance
Effectiveness (Affixture)	Adequately bring together the stomach and anterior abdominal wall.	"Performance test results demonstrate reasonable assurance that the PUMA-G System can effectively bring together the stomach and anterior abdominal wall..."
Safety (Tissue Harm)	Maintain healthy tissue (no harm during affixture).	"...while maintaining healthy tissue."
Effectiveness (Guidewire)	Reliably capture and retain the guidewire for gastrostomy tube placement.	"The PUMA-G System also reliably captures and retains the guidewire for eventual completion of the gastrostomy tube placement."
Magnetic Force Characterization	Adequate magnetic force for temporary tissue affixture without causing harm.	"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)." (This is a statement about the purpose of the test rather than the quantitative result, but implies the characteristic was met.) The "Performance Data" section also mentions "magnetic force characterization and coupling strength information," suggesting these were measured and found acceptable.
Biocompatibility	Materials are safe for medical use.	"ISO 10993 Compatible" (Table 1)
Sterilization	Device can be reliably sterilized.	"Ethylene Oxide ISO 11135 Validated" (Table 1)
Time (Procedural)	Procedure time is within acceptable limits.	"< 10 Minutes" (Table 1)
Overall Safety and Effectiveness	Reasonable assurance of safety and effectiveness, substantially equivalent to predicate device.	"These data suggest the PUMA-G System is as safe and as effective as the identified predicate device." and "Based upon analysis and valid scientific evidence, reasonable assurance of safety and effectiveness is apparent, therefore concluding that the PUMA-G System is substantially equivalent to its predicate device."

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "Bench performance data were collected..." and refers to "Functional Testing" and "Magnetic Characterization." It also mentions "Post-Market Analysis" for the subject device and "GLP Animal Safety" for the predicate in Table 1. However, specific sample sizes for any test set are not provided in the document. The data provenance seems to be internal company testing, as it's presented as "Bench performance data." The document does not specify country of origin or whether the studies were retrospective or prospective, though bench testing is inherently prospective for the device being tested.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

The document does not describe any studies involving human experts establishing ground truth for a test set. The performance data discussed appears to be primarily technical/mechanical bench testing.

4. Adjudication Method for the Test Set:

Not applicable, as no expert-based test set or adjudication process is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned or described in the provided text. The evaluation method appears to be focused on the device's technical performance and comparison to a predicate device based on technological characteristics and bench testing.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done:

The PUMA-G System is a physical medical device (catheter, guidewire, external magnet), not an algorithm or AI-driven system. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. The device facilitates a procedure for human users.

7. The Type of Ground Truth Used:

For the bench performance tests mentioned, the "ground truth" would be established by:

Physical measurements and engineering standards: For magnetic force characterization, coupling strength, and mechanical performance.
Biocompatibility standards: ISO 10993 for materials.
Sterilization validation standards: ISO 11135 for ethylene oxide sterilization.
Animal safety data: Referenced for the predicate device ("GLP Animal Safety"), likely pathological or physiological outcomes.

8. The Sample Size for the Training Set:

The concept of a "training set" typically applies to machine learning or AI algorithms. Since the PUMA-G System is a mechanical device, there is no training set in the traditional sense of AI algorithm development. Device development likely involves iterative design, prototyping, and testing, but not a "training set" for an algorithm.

9. How the Ground Truth for the Training Set was Established:

As there is no training set for an AI algorithm, this question is not applicable.

Summary

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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

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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)

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 700Baltimore, MD 21230
Phone Number	(443) 574-6981
Contact Person	Jack Kent, MBA MPHChief Commercialization Officer
Date Prepared	March 18, 2023

Device Information

Trade Name	PUMA-G System
Common Name	Gastrostomy Aid
Classification	Gastrointestinal tube and accessories21 CFR 876.5980 (Product Code KGC)

Predicate Device Information

Device Name	PUMA-G System
K Number	K183057

Device Description

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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

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 DevicePUMA-G System	Predicate Device (K183057)PUMA-G System	Comparison
Mechanism (General)	Mechanical (affix stomach toanterior abdominal wall)	Mechanical (affix stomach toanterior abdominal wall)	Same
Mechanism (Detail)	Magnetic Attraction	Magnetic Attraction	Same
Time	< 10 Minutes	< 10 Minutes	Same
Materials	ISO 10993 Compatible	ISO 10993 Compatible	Same
Sterilization	Ethylene OxideISO 11135 Validated	Ethylene OxideISO 11135 Validated	Same
Procedural Requirements	OrogastricOver-the-Wire and Pull TubesUltrasound Visualization	OrogastricOver-the-Wire TubesUltrasound Visualization	Minor DifferencesNo Impact on SE Decision
Performance Testing	Functional TestingMagnetic CharacterizationPost-Market Analysis	BiocompatibilitySterilizationFunctional TestingMagnetic CharacterizationGLP Animal Safety	EquivalentPerformance Data ResultsShow Do Not Raise New orDifferent Issues of Safety andEffectiveness

Table 1: Comparison of Technological Characteristics

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Image /page/5/Picture/0 description: The image shows the logo for COAPTECH. The logo features a stylized design resembling two magnets facing each other, with blue curved shapes forming the core and green rectangles at the ends representing the magnetic poles. Below the symbol, the company name "COAPTECH" is written in a blue, sans-serif font.

Performance Data

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.

Conclusions

The PUMA-G System and predicate device have the same intended use and similar indications, both serving as medical devices to aid in the placement of gastrostomy tubes. Based upon analysis and valid scientific evidence, reasonable assurance of safety and effectiveness is apparent, therefore concluding that the PUMA-G System is substantially equivalent to its predicate device.

Regulation Number and Section

§ 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.