The Kangaroo™ Enteral Feeding Syrinqe with ENFit Connector delivers nutritional formula to the gastrointestinal system of a patient who is physically unable to eat and swallow. The feeding syringes are intended to be used in clinical or home care settings by users ranging from laypersons to clinicians (under the supervision of a clinician), to administer enteral nutrition. The syringe is intended for all age groups.

Device Description

The Kangaroo™ Enteral Feeding Syringe with ENFit Connector consists of disposable enteral feeding syringes that deliver formula to provide nutrition for those who do not have the ability to orally ingest food. The device incorporates a female ENFit connector for connection to an enteral access device.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Kangaroo™ Enteral Feeding Syringe with ENFit Connector. It is a submission for a device that is substantially equivalent to a predicate device, focusing on non-clinical testing to demonstrate safety and effectiveness.

Here's an analysis of the provided information against your request:

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

The document lists several tests conducted in accordance with ISO 80369-3 and ISO 80369-20. The "acceptance criteria" are implied by the "Requirement is in:" columns, referring to specific clauses in ISO 80369-3, and the "reported device performance" is generally stated as "The testing demonstrates the proposed devices conform to the requirements of ISO 80963-3." Specific quantitative performance values are not provided in this summary.

Test	Acceptance Criteria (ISO 80369-3 Clause)	Reported Device Performance
Fluid Leakage	Clause 6.2	Conforms to requirements of ISO 80963-3
Stress Cracking	Clause 6.3	Conforms to requirements of ISO 80963-3
Resistance to separation from axial load	Clause 6.4	Conforms to requirements of ISO 80963-3
Resistance to separation from unscrewing	Clause 6.5	Conforms to requirements of ISO 80963-3
Resistance to overriding	Clause 6.6	Conforms to requirements of ISO 80963-3
Disconnection by unscrewing	Clause 6.7	Conforms to requirements of ISO 80963-3
Dimensional analysis	Table B.2 of ISO 80369-3	Conforms to Table B.2 of ISO 80963-3
Minimum through diameter flow testing	(Implied performance objective)	Exceeds the performance of the predicate device
Biocompatibility testing	(Implied biological safety standards)	Demonstrated the biological safety of indirect contact parts
Stability testing	(Implied shelf-life/aging standards)	Evaluated properties after accelerated aging
Risk associated with misconnection	(Implied acceptable risk level)	Assessed and captured in various reports
Usability and human factors testing	(Implied usability/safety standards)	Conducted and captured in a validation study

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

The document does not specify the sample sizes for any of the non-clinical tests (e.g., number of syringes tested for fluid leakage, stress cracking, etc.). It also does not explicitly state the data provenance (country of origin, retrospective/prospective). However, given that these are non-clinical engineering and bench tests, "data provenance" in the context of clinical studies (like patient demographics or retrospectivity) is not directly applicable. These tests would be conducted in a laboratory setting by the manufacturer, or a certified testing lab.

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)

This request is not applicable to the provided document. The study described is a non-clinical performance evaluation of a physical medical device (enteral feeding syringe) against engineering standards (ISO 80369-3/20). There is no "ground truth" in the sense of expert medical diagnosis or interpretation that would require a panel of experts. The "ground truth" here is adherence to the specified technical standards.

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

Not applicable. As noted above, this involves non-clinical engineering testing against predefined standards, not a diagnostic or interpretive task requiring adjudication by experts.

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 a study involving human readers, AI, or diagnostic imaging. It is a submission for a physical medical device.

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

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

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

The "ground truth" for the non-clinical tests is adherence to the specified international standards, specifically ISO 80369-3: Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications and ISO 80369-20: Common test methods. This is equivalent to established, recognized engineering and safety standards.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of non-clinical device testing.

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

Not applicable. As there is no training set, this question is not relevant.

In summary, the provided document describes a 510(k) submission for a physical medical device (enteral feeding syringe). The "study" refers to a series of non-clinical engineering and bench tests designed to demonstrate conformity to ISO standards for small-bore connectors. The questions regarding expert consensus, clinical ground truth, training/test sets, and AI/human reader performance are not applicable to the nature of this particular device approval process.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 29, 2016

Covidien Shannon Green Sr. Regulatory Affairs Product Specialist 15 Hampshire Street Mansfield, MA 02048

Re: K142128

Trade/Device Name: Kangaroo™ Enteral Feeding Syringe with ENFit Connector Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: PNR Dated: January 15, 2015 Received: January 16, 2015

Dear Shannon Green,

This letter corrects our substantially equivalent letter of February 23, 2015.

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. 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.

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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 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely,

For Division

Douglas Silverst 2016.09 29 08:02:4

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

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Indications for Use Statement

Indications for Use

510(k) Number (if known): K142128

Device Name:

Kangaroo™ Enteral Feeding Syringe with ENFit Connector

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

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510(k) Summary

Kangaroo™ Enteral Feeding Syringe with ENFit Connector

In accordance with section 513(i) of the SMDA and as defined in 21CFR Part 807.92 this summary is submitted by:

Covidien 15 Hampshire Street Mansfield, MA 02048 Date Prepared: July 31, 2014

a. Contact Person
Shannon Green Sr. Regulatory Affairs Specialist Covidien Telephone: (508) 261-8587 Fax: (508) 261-8461
b. Name of Medical Device
Common Name: Gastrointestinal tubes with enteral specific connectors

U.S. FDA Classification Product Code: PIF

U.S. Regulation Description: Gastrointestinal tube and accessories, 21 CFR 876.5980

Proprietary / Trade Name: Kangaroo™ Enteral Feeding Syringe with ENFit Connector

c. Identification of Legally Marketed Device(s)

BD™ Oral/Enteral Syringe with BD UniVia™ Connection, K112434

d. Device Brief Description

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e. Device Intended Use

The Kangaroo™ Enteral Feeding Syringe with ENFit Connector delivers nutritional formula to the gastrointestinal system of a patient who is physically unable to eat and swallow. The feeding syringes are intended to be used in clinical or home care settings by users ranging from laypersons to clinicians (under the supervision of a clinician), to administer enteral nutrition. The syringe is intended for all age groups.

f. Product Comparison Summary

The proposed and predicate enteral feeding svringes are intended for patients who require enteral feeding due to illness or injury which prevents normal chewing and swallowing. These products are enteral feeding syringes that have the same intended use, the same function, and the same general characteristics.

g. Nonclinical testing

o Biocompatibility testing has demonstrated the biological safety of parts of the medical device which may indirectly contact the patient.
. Stability testing evaluated the properties of the enteral feeding syringes after accelerated aging in support of the labeling.
. Dimensional analysis was conducted for critical dimensions of the Kangaroo™ Enteral Feeding Syringes with ENFit Connectors, in accordance with ISO 80369-3. Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications. The testing demonstrates the proposed devices conform to Table B.2 of ISO 80963-3.
. Testing performed on the Kangaroo™ Enteral Feeding Syringes with ENFit Connectors included the items listed below, in accordance with ISO 80369-3, Smallbore connectors for liquids and gases in healthcare applications – Part 3: Connectors for enteral applications, using the test methods provided in ISO 80369-20. Smallbore connectors for liguids and gases in healthcare applications - Part 20: Common test methods. The testing demonstrates the proposed devices conform to the requirements of ISO 80963-3.

Test	80369-3 Requirementis in:	80369-20 Test Methodis in:
Fluid Leakage	Clause 6.2	Annex C
Stress Cracking	Clause 6.3	Annex E
Resistance to separationfrom axial load	Clause 6.4	Annex F
Resistance to separationfrom unscrewing	Clause 6.5	Annex G
Resistance to overriding	Clause 6.6	Annex H
Disconnection byunscrewing	Clause 6.7	Annex I

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Minimum through diameter flow testing was conducted and demonstrates the . Kangaroo™ Enteral Feeding Syringes with ENFit Connectors exceeds the performance of the predicate device.
. The risk associated the misconnection of the ENFit connector has been assessed at length and captured in the following documents, which are located in Mater File 2258.
- PG Lock Misconnection Data with FMEA 2014-01-9 o
- 3595-0501-04 Enteral Connector Misconnection Assessment o
- Enteral Connection Risk Management Report Rev 2.0 o
- PG Lock Misconnection Risk Assessment Report 041513 o
Usability and human factors testing was conducted as part of the ENFit . connector, and is captured in the following document, which is located in the Master File 2258.
- o Human Factors Validation Study Enteral Connectors Final Report

h. Clinical testing

Clinical evaluations were not relied upon for evidence of safety of effectiveness, or for a determination of substantial equivalence.

i. Conclusions

The information provided within this pre-market notification demonstrates that the Kangaroo™ Enteral Feeding Syringe with ENFit Connector has no difference that would affect the safety of effectiveness of the devices as compared to the predicate device.

End of Summary

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.