A non-sterile gravity medicine delivery device for use with a nasogastric or percutaneous endoscopic gastrostomy ( PEG) tube to administer crushed and diluted medications and liquids.

Device Description

The FROG is functionally similar to the syringe used for delivery of "bolus feedings and medications through a nasogastric feeding tube or a "Peg" feeding tube. By adapting the tip of the syringe barrel to accommodate the secondary medication tubing, adding a cap and hanger and enlarging the barrel of the syringe to accommodate the 240cc capacity, the FROG is capable of delivering a can (240cc) of feeding or medications, hands free and accurately without spillage or waste. The FROG is made of polypropolene, latex free and dishwasher safe for home use. The drip chamber on the delivery tubing allows for back priming in the event crushed medication particles clump and cause a blockage in the flow.

AI/ML Overview

The provided text describes a medical device called "The FROG" (Fluids- Rx medications- On the Go), which is a dosage vessel for indwelling feeding tubes. The 510(k) summary focuses on demonstrating substantial equivalence to existing devices rather than meeting specific performance acceptance criteria through detailed studies. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics for a typical AI/software device is not present in this document.

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance

The document does not specify formal, quantitative acceptance criteria in the typical sense for a medical device with measurable performance metrics (e.g., sensitivity, specificity, accuracy). The "performance" described is functional similarity to existing devices and addressing identified user pain points.

Acceptance Criteria (Implied)	Reported Device Performance
Functional similarity to existing syringes for bolus feedings/meds.	The FROG is functionally similar to the syringe used for delivery of "bolus feedings and medications through a nasogastric feeding tube or a "Peg" feeding tube. It adapts the syringe barrel tip to accommodate secondary medication tubing, adds a cap and hanger, and enlarges the barrel to 240cc.
Deliver a can (240cc) of feeding or medications.	Capable of delivering a can (240cc) of feeding or medications.
Deliver hands-free.	Capable of delivering hands-free.
Deliver accurately without spillage or waste.	Capable of delivering accurately without spillage or waste.
Mitigate blockages from crushed medication particles.	The drip chamber on the delivery tubing allows for back priming in the event crushed medication particles clump and cause a blockage. (This is presented as an improvement over existing syringes that don't accommodate alternatives, requiring disconnection and risking loss of medication/feeding).
Control flow rate.	In a single clinical test, the shortened 60cc syringe tip with secondary medication tubing provided a more controllable (using the roller clamp) flow rate.
Resolve reflux issues.	In subsequent non-clinical testing, the airway on the tubing, the cap, and the hanger have proven to resolve reflux issues. (Note: Initial clinical test with shortened syringe tip still had reflux problems).
Ease and accuracy of use; relief of anxiety over dosing.	A clinical test of the "FROG" with cap and hanger via the "BUTTON" access reported ease and accuracy of use and relief of anxiety related to fear of inaccurate dosing. (This refers to a qualitative assessment of user experience).
Material properties.	Made of polypropylene, latex-free, and dishwasher safe for home use. (These are material specifications rather than performance criteria in the sense of functional output, but are important for safety and usability.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size:
- "In a single clinical test": The sample size is not explicitly stated but implies a very small number, possibly one client ("a client who was capable of giving self feedings and medications").
- "A clinical test of the 'FROG' with cap and hanger was performed via the 'BUTTON' access, popular for use in children": Again, the sample size is not explicitly stated but suggests potentially a few "children" or "clients." Given the qualitative nature of the findings ("ease and accuracy of use was reported and the level of anxiety related to fear of inaccurate dosing was relieved"), it is unlikely to be a large, statistically powered study.
Data Provenance: Not specified, but the submission is from Branchville, NJ, USA, so it's reasonable to infer the testing took place in the USA.
Retrospective or Prospective: The descriptions "In a single clinical test" and "A clinical test [...] was performed" suggest prospective testing, even if small in scale and scope.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a mechanical delivery system, and its "ground truth" is its functional performance and user experience, not diagnostic accuracy requiring expert consensus. The "ease and accuracy of use" and "relief of anxiety" were reported by the users or caregivers in the clinical tests, acting as the subjective "truth-tellers." No external experts for ground truth establishment are mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As noted above, this summary describes functional testing and user feedback, not a study requiring an adjudication method for ground truth or performance assessment.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI or diagnostic device that involves "human readers."

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an AI or algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" is primarily based on:

Functional observation: Does it deliver 240cc? Does it flow hands-free? Does it prevent spillage?
User feedback/reported experience: "Ease and accuracy of use was reported" and "the level of anxiety related to fear of inaccurate dosing was relieved."
Direct observation of physical phenomena: "The airway on the tubing, the cap and hanger have proven to resolve these issues (reflux) as well."

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable for the same reason as above.

Summary

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K072831
Pg 1 of 3

(h) 510 (k) Summary

DEC 12 2008

Submitter's name: Karla N Coombs 21 Union Turnpike Branchville, NJ 07826 973-948-3796

Karla N Coombs Contact person:

October 2, 2007 Date prepared:

Name of device:

Dosage vessel to be used with a indwelling feeding tube.

Trade name:

FROG = Fluids- Rx( medications)- Qn the- Go See Logo on label information

Equivalence data:

The FROG is made of polypropolene, latex free and dishwasher safe for home use.

The drip chamber on the delivery tubing allows for back priming in the event crushed medication particles clump and cause a blockage in the flow. The syringe currently used to give medications

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K072831 pg 2 of 3

(h) 510 k Summary continued

does not accommodate any alternative in this area and the caregiver has no choice but to disconnect the syringe from the patient's feeding tube and risk loss of medication or feeding in the process.

In a single clinical test, the 60cc syringe tip was shortened and a secondary medication tubing was inserted into the tip to provide a more controllable (using the roller clamp) flow rate for a client who was capable of giving self feedings and medications. The reflux continued to be a problem, with no untoward effects physically on the client and in subsequent non-clinical testing, the airway on the tubing, the cap and hanger have proven to resolve these issues as well. The plunger was not used, as bolus feedings and medication are to be given by gravity. *

A clinical test of the "FROG" with cap and hanger was performed via the "BUTTON" access, popular for use in children. The ease and accuracy of use was reported and the level of anxiety related to fear of inaccurate dosing was relieved.

*Perry & Potter-Clinical Nursing Skills & Techniques-5 the Edition.

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K072831 pg 30f3

(h) 510 k Summary continued

In conclusion, the FROG, will prove to be a welcomed relief to those already burdened with the inability to eat and swallow as they have done under normal circumstances in the past. This device will allow them and their caregivers more freedom to go about their activities of daily living with less disruption in their routine and ease in their ability to be medicated, hydrated and nourished.

Respectively submitted,

Karla N Coombs

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird with stylized wings and tail feathers. The image is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 2 2008

Karla N. Coombs, R.N. Owner Newby-Coombs, L.L.C. 21 Union Turnpike P.O. Box 20. BRANCHVILLE NJ 07826

K072831 Re:

Trade/Device Name: The FROG Device Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: FPD Dated: November 25, 2008 Received: December 2, 2008

Dear Ms. Coombs:

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. 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 such 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 Rederal Register.

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Page 2

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); 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.

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 (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology	240-276-011
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-011
21 CFR 894.xxx	(Radiology)	240-276-012
Other		240-276-010

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Jorge M. Zhang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): KO72831

Device Name: The FROG Device

Indications for Use:

A non-sterile gravity medicine delivery device for use with a nasogastric or percutaneous endoscopic gastrostomy ( PEG) tube to administer crushed and diluted medications and liquids.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dulla Reen

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number.

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.