Single use O-ring gasket syringe with ENFit connector (provided sterile and non-sterile):
The device is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body orally or enterally. It is intended to be used in clinical settings by users ranging from clinicians to laypersons in all age groups.

Reusable O-ring gasket syringe with ENFit connector-(provided non-sterile):
The device is indicated for use as a dispenser, a measuring device. It is used to deliver fluids into the body orally or enterally. It is intended to be used multiple times in non-clinical settings by users ranging from clinicians to laypersons in all age groups. The device is indicated for single patient use only.

Device Description

The proposed device is manual feeding syringe, used as a dispenser, a measuring device, and a fluid transfer device. And it is used to deliver fluids into the body orally or enterally in clinical and non-clinical settings.

There are 2 types of connector for proposed device: Low dose tip ENFit connector(1ml to 6ml) and Standard ENFit connector(12ml to 60ml). The proposed device is standard piston syringe consisting of a plastic hollow barrel with female ENFit connector of ISO 80369-3, plunger, 0-ring piston, Connector of 1ml and 3ml syringe situated centrally, connector of other syringe situated eccentrically. All connectors are compatible only with enteral access or accessories having male ENFit connector of ISO 80369-3. The proposed syringes are available in transparent barrel and amber barrel.

The proposed device is provided sterile or non-sterile, single use or reusable. The sterile device is sterilized by Ethylene Oxide Gas (EtO) to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life. The reusable device is for single patient use only.

The proposed device is made with polypropylene and Silica gel. No DEHP, BPA and Natural Rubber Latex are added in the proposed device. The proposed device also has an optional syringe tip cap.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a medical device (O-ring gasket syringe with ENFit connector). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving a device meets specific acceptance criteria through a large-scale clinical study or AI performance evaluation.

Therefore, the information typically requested in your prompt regarding AI/algorithm performance, ground truth establishment for training and test sets, multi-reader multi-case (MRMC) studies, expert opinions, and sample sizes for AI model development is not present in this document.

The document demonstrates compliance with performance standards for a physical medical device. Here's what can be extracted and inferred based on the document's content:

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

The document doesn't present a table of "acceptance criteria" in a quantitative sense as might be found for algorithm performance (e.g., minimum accuracy). Instead, it lists the standards the device was tested against and states that the test results "demonstrated that the proposed device complies with the following standards." Compliance with these standards is the acceptance criterion for a physical device in this context.

Acceptance Criteria (Standards Complied With)	Reported Device Performance
ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals, AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019)	Complies
ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Test for in vitro cytotoxicity	Complies
ISO 10993-6:2016 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation	Complies
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization	Complies
ISO 10993-11:2017 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity	Complies
USP-NF <151> Pyrogen Test	Complies
ASTM F1929-15 Standard test method for detecting seal leaks in porous medical packaging by dye penetration.	Complies
ASTM F88/F88M-21 standard method for seal strength of flexible barrier materials	Complies
ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection	Complies
USP-NF <85> Bacterial Endotoxins Test	Complies
ISO 7886-1:2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use	Complies
ISO 80369-3:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications	Complies
ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods	Complies
Microbial Enumeration and Specified Microorganisms Tests report	Complies
Cleaning instructions verification	Complies
Re-use cycle parameters study	Complies
Microbial study in simulation using	Complies
Risk assessment in accordance to ISO 14971	Complies
Dosing Accuracy Testing	Complies
Additional Acceptance Criteria for Reusable Devices (implied):
Ability of immediate package to maintain sterility for 5 years	Validated (in accordance with ASTM F1886/F1886M-16, ASTM F88/F88M-21, ASTM F1929-15)
Performance after 5 years accelerated aging	Complies with ISO7886-1 and ISO 80369-3

2. Sample sizes used for the test set and the data provenance:

Sample Size: Not explicitly stated for each test. These would be determined by the specific requirements of each ISO/ASTM standard (e.g., how many units are tested for seal integrity or biocompatibility).
Data Provenance: The tests were "Non-clinical tests" conducted to verify compliance with international standards. The country of origin for the testing itself is not specified, but the applicant (Jiangsu Caina Medical Co., Ltd.) is from China. These are laboratory-based compliance tests, not data collected from human subjects.
Retrospective or Prospective: Not applicable, as these are technical performance tests, not clinical data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable. The "ground truth" for the device's physical performance is established by the definitions and methodologies within the cited international standards (ISO, ASTM, USP-NF). The tests are designed to objectively measure properties and assess compliance according to these universally accepted procedures, not through expert consensus in the way a medical image diagnosis might be.

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

Not applicable. Adjudication methods are typically used for subjective assessments (like medical image interpretation). For compliance testing against engineering and biological standards, the results are typically quantitative measurements that either meet or fail a predefined specification.

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:

No. This type of study (MRMC, human readers, AI assistance) is relevant for AI-powered diagnostic devices. The device in question is a physical syringe, not an AI diagnostic tool.
The document explicitly states: "No clinical study is included in this submission."

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

No. This is not an AI algorithm.

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

For this device, the "ground truth" for proving performance is adherence to established international and national engineering and biological standards. This involves:
- Validated test methods: e.g., the specific procedures for pyrogen testing (USP-NF <151>), seal integrity (ASTM F88/F88M-21), or material biocompatibility (ISO 10993 series).
- Defined acceptance limits/specifications: e.g., allowable residuals of ethylene oxide, specified ranges for dosing accuracy, or criteria for passing cytotoxicity tests.

8. The sample size for the training set:

Not applicable. This is not an AI model requiring a training set.

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

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

September 16, 2022

Jiangsu Caina Medical Co., Ltd. Jianwei Pan Regulatory Affairs No. 23, Huanxi Road, Zhutang Town Jiangyin, Jiangsu 214415 China

Re: K222155

Trade/Device Name: O-ring gasket syringe with ENFit connector (single use or reusable) Oral/Enteral syringe with ENFit connector (single use or reusable) Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: PNR Dated: July 15, 2022 Received: July 20, 2022

Dear Jianwei Pan:

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.

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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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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) K222155

Device Name

O-ring gasket syringe with ENFit connector (single use or reusable) Oral/Enteral syringe with ENFit connector (single use or reusable)

Indications for Use (Describe)

Single use O-ring gasket syringe with ENFit connector (provided sterile and non-sterile):

The device is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body orally or enterally. It is intended to be used in clinical settings by users ranging from clinicians to laypersons in all age groups.

Reusable O-ring gasket syringe with ENFit connector-(provided non-sterile):

The device is indicated for use as a dispenser, a measuring device. It is used to deliver fluids into the body orally or enterally. It is intended to be used multiple times in non-clinical settings by users ranging from clinicians to laypersons in all age groups. The device is indicated for single patient use 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)

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/3/Picture/2 description: The image shows the logo for CAINAmed. The logo consists of the word "CAINA" in large, blue, sans-serif letters, with a small green triangle above the "I" and the second "A". Below the word "CAINA" is the website address "www.cainamed.com" in a smaller, sans-serif font.

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K222155

1. Date of Preparation: July 08, 2022
1. Sponsor Identification

Jiangsu Caina Medical Co., Ltd.

No.23, Huanxi Road, Zhutang Town, Jiangyin, Jiangsu, 214415, China

Establishment Registration Number: 3005670221

Contact Person: Jun Lu

Position: General Manager

Tel: +86-510-86205183

Fax: +86-510-86215183

Email: jun.lu(@cainamed.com

1. Designated Submission Correspondent
  Mr. Jianwei pan (Primary Contact Person) Email: jianwei.pan@cainamed.com Ms. Tracy Gong (Alternative Contact Person) Email: tracy.gong(@cainamed.com Tel: +86-510-86866666-8027 Fax: +86-510-86866666-8009
1. Identification of Proposed Device
  Trade Name: O-ring gasket syringe with ENFit connector (single use or reusable) Oral/Enteral syringe with ENFit connector (single use or reusable)

Regulatory Information

Classification Name: Gastrointestinal tube and accessories Produce Code Name: Enteral syringes with enteral specific connectors Classification: II Product Code: PNR Regulation Number: 21 CFR 876.5980 Review Panel: Gastroenterology/Urology 1 / 6

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Image /page/4/Picture/2 description: The image shows the logo for CAINAmed. The logo consists of the word "CAINA" in blue, with a green triangle in the middle of the A's. Below the word "CAINA" is the website address "www.cainamed.com".

Indications for Use Statement:

Single use O-ring gasket syringe with ENFit connector (provided sterile and non-sterile): The device is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body orally or enterally. It is intended to be used in clinical and nonclinical settings by users ranging from clinicians to laypersons in all age groups.

Reusable O-ring gasket syringe with ENFit connector (provided non-sterile):

The device is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body orally or enterally. It is intended to be used multiple times in non-clinical settings by users ranging from clinicians to laypersons in all age groups. The device is indicated for single patient use only.

ર. Device Description

The proposed device is provided sterile or non-sterile, single use or reusable. The sterile device is sterilized by Ethylene Oxide Gas (EtO) to achieve a SAL of 106 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life. The reusable device is for single patient use only.

The proposed device is made with polypropylene and Silica gel. No DEHP, BPA and Natural Rubber Latex are added in the proposed device. The proposed device also has an optional syringe tip cap.

న్. Identification of Predicate Device
Predicate Device 510(k) Number: K183540 Product Name: Oral/Enteral Syringes with ENFit® connector (12 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringes with ENFit® connector (1 mL to 6 mL)
1. Non-Clinical Test Conclusion

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Image /page/5/Picture/2 description: The image shows the logo for CAINA. The logo is blue and green. The text "www.cainamed.com" is below the logo.

Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization > residuals, AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019)
ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Test for in vitro cytotoxicity
ISO 10993-6:2016 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
ISO 10993-11:2017 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
USP-NF <151> Pyrogen Test
ASTM F1929-15 Standard test method for detecting seal leaks in porous medical packaging by dye penetration.
ASTM F88/F88M-21 standard method for seal strength of flexible barrier materials
ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
USP-NF <85> Bacterial Endotoxins Test
ISO7886-1:2017 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
♪ ISO80369-3:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications
A ISO80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods

In addition, the following verification or testing is performed to meet the stated performance requirements:

Microbial Enumeration and Specified Microorganisms Tests report
A Cleaning instructions verification
A Re-use cycle parameters study
♪ Microbial study in simulation using
A Risk assessment in accordance to ISO 14971
Dosing Accuracy Testing
1. Clinical Test Conclusion

No clinical study is included in this submission.

1. Substantially Equivalent (SE) Comparison

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Image /page/6/Picture/2 description: The image shows the logo for CAINA. The logo is blue and green. The text "CAINA" is in blue, with a green triangle in the middle of the "A"s. Below the text "CAINA" is the website address "www.cainamed.com".

ITEM	Proposed Device	Predicate Device K183540	Comment
Product code	PNR	PNR	Same
Regulation No.	21 CFR 876.5980	21 CFR 876.5980	Same
Regulation Name	enteral syringes with enteral specific connectors	enteral syringes with enteral specific connectors	Same
Regulation Class	II	II	Same
Indications for use	Single use O-ring gasket syringe withENFit connector (provided sterile andnon-sterile):The proposed device is indicated foruse as a dispenser, a measuring deviceand a fluid transfer device. It is usedto deliver fluids into the body orallyor enterally. It is intended to be usedin clinical and non-clinical settings byusers ranging from clinicians tolaypersons in all age groups.Reusable O-ring gasket syringe withENFit connector (providednon-sterile):The proposed device is indicated foruse as a dispenser, a measuring deviceand a fluid transfer device. It is usedto deliver fluids into the body orallyor enterally. It is intended to be usedmultiple times in non-clinical settingsby users ranging from clinicians tolaypersons in all age groups. Thedevice is indicated for single patientuse only.	Single Use Oral/Enteral Syringeswith ENFit Connector (providedsterile and non-sterile): The deviceis indicated for use as a dispenser, ameasuring device and a fluidtransfer device. It is used to deliverfluids into the body orally orenterally. It is intended to be used inclinical and non-clinical settings byusers ranging from clinicians tolaypersons in all age groups.Reusable Oral/Enteral Syringes withENFit Connector (providednon-sterile): The device is indicatedfor use as a dispenser, a measuringdevice and a fluid transfer device. Itis used to deliver fluids into thebody orally or enterally. It isintended to be used multiple times innon-clinical settings by usersranging from clinicians tolaypersons in all age groups. Thedevice is indicated for single patientuse only.	Same
Configuration	Piston (gasket type);Plunger;Barrel with integral ENFit connector;Tip cap(optional)	Gasket;Plunger;Barrel with integral ENFit connector	SeeComment1
Product Size	Low dose tip ENFit connectorSyringe: 1ml, 3ml, 6mlStandard ENFit connector Syringe:	Low dose tip ENFit connectorSyringe: 1ml to 6mlStandard ENFit connector Syringe:	Same
	12ml, 20ml, 35ml, 60ml	12ml- 60ml
Material	Polypropylene	Polypropylene	SeeComment2
	Silica gel	Silicone
	Polydimethysiloxane	Polydimethylsiloxane
	Purple color additive	White Colorant
ExpirationDate	5 years	3 years	SeeComment3
Sterile	Sterile and non-sterile	Sterile and non-sterile	Same
Sterilemethod	EtO Sterilized(only sterile device)	EtO Sterilized(only sterile device)	Same
SAL	10 -6(only sterile device)	10 -6(only sterile device)	Same
Single use	Single use or single patient use	Single use or single patient use	Same
Userpopulation	From clinicians to laypersons(Rx andOTC)	From clinicians to laypersons(Rxand OTC)	Same
Patientpopulation	In all age groups	In all age groups	Same
Environmentof Use	clinical and non-clinical settings	clinical and non-clinical settings	Same
PerformanceTesting	Complied with:ISO 80369-3;ISO 7886-1;	Complied with:ISO 80369-3;ISO 7886-1;	Same
	Biocompatibility	Acute systemic toxicityISO 10993-11:2017 Third edition
ImplantationISO 10993-6:2016 Third edition
CytotoxicityISO 10993-5:2009 Third edition		Cytotoxicity: ISO 10993-5;
IrritationISO 10993-10:2010 Third edition		Irritation and Sensitization: ISO10993-10;
PyrogenUSP <151> USP- NF2017		Acute systemic toxicity: ISO10993-11;
SensitizationISO 10993-10:2010 Third edition
Subacute toxicityISO 10993-11:2017 Third edition

Table 1 Comparison of Technology Characteristics with K183540

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Image /page/7/Picture/1 description: The image shows the logo for CAINA. The logo consists of the word "CAINA" in blue, with a green triangle in the middle of the "A". Below the word "CAINA" is the website address "www.cainamed.com" in a smaller font. The logo is simple and clean, and the colors are bright and eye-catching.

Comment 1

The optional tip cap is used to prevent fluid loss and contamination of syringe contents until ready for use. This added cap does not affect substantially equivalence on safety and effectiveness.

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Image /page/8/Picture/2 description: The image shows the logo for CAINAmed. The logo consists of the word "CAINA" in blue, with a green triangle in the middle of the "A"s. Below the word "CAINA" is the website address "www.cainamed.com".

Comment 2

Differences in materials between the predicate and subject device were addressed through Biocompatibility test.

Comment 3

The expiration date for the proposed device is different from predicate device. The proposed devices have been performed 5 years accelerated aging and demonstrated that the aged samples also complied with the requirements of ISO7886-1 and ISO 80369-3. The ability of immediate package of the proposed device to maintain the device in a sterile state for a period of 5 years has been validated in accordance with ASTM F1886/F1886M-16, ASTM F88/F88M-21, ASTM F1929-15. Therefore, this expiration date difference does not affect substantially equivalence on safety and effectiveness.

Comment 4

The biocompatibility for the proposed device is different from predicate device. The contact duration for the proposed device is stated up to 14 day. According to guidance, Use of International Standard ISO 10993-1 "Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process", the Pyrogen test, Subacute Systemic Toxicity test, Implantation test are added for evaluation endpoint and meet the requirements of biocompatibility.

9. Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device. The nonclinical testing demonstrates that the proposed device is as safe, as effective, and performs as well as the 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.