(225 days)
The Cedic Enteral Distal End ENFit Transition Connector is intended for connecting an enteral giving set with an ENFit connector to an enteral catheter with funnel.
The Cedic Enteral ENFit Transition Connector for Medication Port is intended for connecting a male oral tip syringe to an enteral giving set or enteral catheter with an ENFit medication port.
The Cedic Enteral Funnel ENFit Transition Connector is intended for connecting an enteral giving set equipped with a stepped enteral distal end to an enteral catheter equipped with an ENFit connector.
Cedic Srl has designed three transition connectors that will allow specific connections between PGLock end connectors being used on new devices to some of the previously used end connectors that may still be in use in healthcare or home settings. The three transition connectors are:
- . Enteral Distal End ENFit Transition Connector, for connecting an enteral giving set with an ENFit connector to an enteral catheter with funnel. Available with and without end cap.
- . Enteral ENFit Transition Connector for Medication Port, for connecting a male oral tip syringe to an enteral giving set or enteral catheter with an ENFit medication port. Available with and without end cap.
- . Enteral Funnel ENFit Transition Connector, for connecting an enteral giving set equipped with a stepped enteral distal end to an enteral catheter equipped with an ENFit connector. Available with and without end cap.
All three Cedic ENFit Transition Connectors are intended for prescription use only.
The provided document is a 510(k) summary for Cedic ENFit Transition Connectors for Enteral Applications. It outlines the device's description, indications for use, and performance data to demonstrate substantial equivalence to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and study information based on the provided text, categorized as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The document references FDA draft guidance for safety considerations for 510(k) submissions to mitigate misconnections with small-bore connectors for enteral applications. It discusses three key areas for performance data and how the Cedic ENFit Transition Connectors meet these recommendations.
| Acceptance Criteria (from FDA Draft Guidance) | Reported Device Performance and Compliance |
|---|---|
| A. Connector Materials: Enteral connectors should be made of rigid materials, as described in AAMI/ANSI/ISO 80369-1, Clause 4, with testing according to ASTM D747 or ASTM D790, or equivalent, to reduce the likelihood of forced fits. (Quote from Section VI.A of FDA Draft Guidance) | Compliance: "In this respect, the Cedic ENFit Transition Connectors are made of the appropriate rigid or semi-rigid materials." Materials Used: ABS HF 380, LDPE (Riblene MM20), or soft PVC (Nakan FMA919N). One component (end cap) is colored with Remafin Violet PE43076356-ZT (2%). These materials were previously used for the Cedic Enteral Feeding Spike Adapter (K072652). |
| B. Mechanical Testing of Enteral Connectors to Assess Incompatibility: Mechanical force testing following AAMI/ANSI/ISO 80369-1, Clause 5.8, Annex B methods, or an equivalent alternative, to demonstrate that enteral connectors are non-interconnectable with connectors from other health care applications. (Quote from Section VI.B of FDA Draft Guidance) | Compliance: "Bench tests have been carried out on samples of the Cedic ENFit Transition Connectors for Enteral Applications." Specific Tests Performed: - Enteral connector misconnection assessment - Human factors - Fluid leakage - Stress cracking - Resistance to separation from axial load - Resistance to separation from unscrewing - Resistance to overriding - Disconnection by unscrewing |
| C. Enteral Connector Risk Assessment: Submit a risk assessment to demonstrate effective mitigation of misconnection risk, with objective evidence that risks have been reduced to acceptable levels according to ISO 14971:2007 or equivalent. (Quote from Section VI.C of FDA Draft Guidance) | Compliance: "In this respect, this 510(k) submission includes a copy of the risk analysis for the three subject transition connectors." |
2. Sample Size Used for the Test Set and the Data Provenance
The document states, "Bench tests have been carried out on samples of the Cedic ENFit Transition Connectors for Enteral Applications." It does not specify the exact sample size for these tests. The data provenance is implied to be laboratory testing conducted by the manufacturer, Cedic S.r.l., which is based in Italy. The tests appear to be prospective, specifically performed for this 510(k) submission to demonstrate compliance with the referenced FDA guidance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The performance data described relates to mechanical and physical testing of the connectors, which typically does not involve expert readers or ground truth established by medical professionals in the same way, for example, an imaging diagnostic device would.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided in the document. Mechanical and physical tests do not typically involve adjudication by multiple experts in the manner of clinical or imaging studies. The results of the bench tests would likely be based on objective measurements against predefined pass/fail criteria.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done and is not applicable to this type of device. The devices are transition connectors for enteral feeding, not diagnostic imaging or AI-assisted diagnostic tools.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and therefore not provided in the document. The device is a physical connector, not an algorithm, so standalone algorithm performance is irrelevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied to diagnostic algorithms is not directly applicable here. For the mechanical and physical tests performed, the "ground truth" or reference standard would be the specified technical requirements and performance parameters outlined in the AAMI/ANSI/ISO 80369-1 standard and the FDA's draft guidance. For example, for fluid leakage, the ground truth would be a defined maximum allowable leakage rate. For resistance to separation, it would be a minimum force or torque the connection must withstand.
8. The Sample Size for the Training Set
This information is not provided and is not applicable. The device is a physical medical connector, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not provided and is not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three human profiles facing right, connected by a flowing line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 17, 2014
Cedic S.r.1. % Roger Gray VP. Ouality and Regulatory Donawa Lifescience Consulting S.r.l. Piazza Albania, 10 Rome 00153 Italy
Re: K140581 Trade/Device Name: Cedic Enteral Distal End ENFit Transition Connector Cedic Enteral ENFit Transition Connector for Medication Port Cedic Enteral Funnel ENFit Transition Connector Regulation Number: 21 CFR& 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: PIO Dated: September 16, 2014 Received: September 19, 2014
Dear Roger Gray,
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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" (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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -A
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
510(k) Number (if known) K140581
Device Name
Cedic Enteral Distal End ENFit Transition Connector
Indications for Use (Describe)
The Cedic Enteral Distal End ENFit Transition Connecting an enteral giving set with an ENF'it connector to an enteral catheter with funnel.
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)
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"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."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140581
Device Name
Cedic Enteral ENFit Transition Connector for Medication Port
Indications for Use (Describe)
The Cedic Enteral ENFit Transition Connector for Medication Port is intended for connecting a male oral tip syringe to an enteral giving set or enteral catheter with an ENFit medication port.
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)
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda hhs gov
"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."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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Indications for Use
510(k) Number (if known) K140581
Device Name
Cedic Enteral Funnel ENFit Transition Connector
Indications for Use (Describe)
The Cedic Enteral Furnel ENFit Transition Connecting an enteral giving set equipped with a stepped enteral distal end to an enteral catheter equipped with an ENFit connector.
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)
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"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/5/Picture/0 description: The image shows the word "Cedic" in a stylized, cursive font. The word is white and has a drop shadow, giving it a three-dimensional effect. The background is a teal color. There is a small circle above the "i" in "Cedic".
510(k) Summary
| Device Name: | Cedic ENFit Transition Connectors for Enteral Applications |
|---|---|
| Type of 510(k) submission: | Traditional |
| Date of Submission: | 28 February 2014 |
| Manufacturer: | Cedic S.r.l.Biomedical DivisionVia Liberazione, 63/920068 Peschiera Borromeo (MI)Italy |
| 510(k) Owner and Contact: | Ms Tiziana MelisRegulatory Affairs ManagerCedic S.r.l.Biomedical DivisionVia Liberazione, 63/920068 Peschiera Borromeo (MI)Italy |
| Phone:Fax:Email: | +39 02 5530 0174+39 02 5530 1487tiziana.melis@cedicbio.com |
| FDA Registration Number: | 3003593728 |
| Owner/Operator Number: | 9063446 |
| 510(k) Submitter and Contact: | Mr Roger GrayVP Quality and RegulatoryDonawa Lifescience ConsultingPiazza Albania 1000153 RomeItaly |
| Phone:Fax:Email: | +39 06 578 2665+39 06 574 3786rgray@donawa.com |
| FDA Product Code: | PIO |
| FDA Regulation Number: | 876.5980 |
| FDA Classification Name: | Enteral Specific Transition Connectors |
| Classification Panel: | Gastroenterology and Urology |
| Common Name: | Transition Connectors for Enteral Applications |
| FDA Classification: | Class II |
| FDA Identification: | Facilitates enteral specific connections between ENFitconnectors and non 80369-1 compliant enteral connectors |
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Image /page/6/Picture/0 description: The image features the word "Cedic" in a stylized, cursive font. The word is white and appears to be glowing slightly, set against a teal background that transitions from a darker shade at the top to a lighter shade at the bottom. The letter "e" in "Cedic" is stylized with a swirl above it.
Device Description
The introduction of new connectors to devices and accessories for enteral feeding applications, in order to help avoid misconnections with devices intended for other clinical applications, has resulted in the short-term need to connectors that will allow devices with existing ('legacy') end connectors to be connected with newer devices having end connectors meeting the relevant requirements of the ISO/IEC 80369 series of standards.
Cedic Srl has designed three transition connectors that will allow specific connections between PGLock end connectors being used on new devices to some of the previously used end connectors that may still be in use in healthcare or home settings. The three transition connectors are:
- . Enteral Distal End ENFit Transition Connector, for connecting an enteral giving set with an ENFit connector to an enteral catheter with funnel. Available with and without end cap.
- . Enteral ENFit Transition Connector for Medication Port, for connecting a male oral tip syringe to an enteral giving set or enteral catheter with an ENFit medication port. Available with and without end cap.
- . Enteral Funnel ENFit Transition Connector, for connecting an enteral giving set equipped with a stepped enteral distal end to an enteral catheter equipped with an ENFit connector. Available with and without end cap.
All three Cedic ENFit Transition Connectors are intended for prescription use only.
Indications for Use/Intended Use
The three ENFit Transition Connectors have the following indications for use/intended use:
The Cedic Enteral Distal End ENFit Transition Connector is intended for connecting an enteral giving set with an ENFit connector to an enteral catheter with funnel.
The Cedic Enteral ENFit Transition Connector for Medication Port is intended for connecting a male oral tip syringe to an enteral giving set or enteral catheter with an ENFit medication port.
The Cedic Enteral Funnel ENFit Transition Connector is intended for connecting an enteral giving set equipped with a stepped enteral distal end to an enteral catheter equipped with an ENFit connector.
Principle of operation, mechanism of action, and interaction with the patient:
All three Cedic ENFit Transition Connectors operate by providing a means of interconnecting incompatible enteral feeding device end fittings together, so that patient enteral feeding can take place when 'new generation' ENFit end fittings need to be connected to previous designs of end fitting.
The ENFit Transition Connectors provide the mating components at each end of the connector that allow connection with the 'new' end fitting at one end of the connection with the 'old' end fitting at the other.
The ENFit Transition Connectors are not intended to come into contact with the patiental contact may occur. The ENFit Transition Connectors have a central fluid path through which feeding fluids flow during the feeding process.
Device Specifications
- . PGLock female to funnel connector: designed to connect an enteral giving set equipped with an ENFit female connector to an enteral catheter equipped with soft funnel port.
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Image /page/7/Picture/0 description: The image shows the word "Cedic" in a stylized, cursive font. The word is white and has a slight shadow effect, giving it a three-dimensional appearance. The background is a solid teal color, which provides a contrasting backdrop for the white text.
- . Male oral tip syringe to PGLock male connector: designed to connect a syringe equipped with male oral tip to a medication port equipped with an ENFit male connector.
- o Stepped connector to PGLock male connector: designed to connect an enteral giving set equipped with stepped connector to an enteral catheter equipped with an ENFit male connector.
Manufacture
All three transition connectors are manufactured by injection molding from ABS HF 380, LDPE (Riblene MM20), or soft PVC (Nakan FMA919N). One component, an end cap, is colored with Remafin Violet PE43076356-ZT (2%). These materials and methods of manufacture have been used previously for the Cedic Enteral Feeding Spike Adapter, cleared by FDA under 510(k) reference K072652.
Performance Data:
In relation to performance data for such ENFit Transition Connectors, according to the FDA publication 'Draft Guidance for Industry and Food and Drug Administration Staff: Safety Considerations for 510(k) Submissions to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications', July 27, 2012:
"Adapters are used to connect enteral devices and provide additional connection points where misconnection events can occur. To mitigate misconnection via adapters, the FDA recommends that adapters be treated similarly to enteral connectors, as described in Section VI.A, B, and C within this guidance. This means that they should be made of rigid or semi-rigid materials, and mechanical testing should be performed according to recommendations described in AAMI/ANSI/ISO 80369-1, or an equivalent alternative, to demonstrate that adapters are specific and compatible for enteral applications only and are non-interconnectable with the connectors of non-enteral devices."
The FDA draft guidance includes in Section VI. A, B and C the following recommendations:
A. Connector materials
"FDA recommends that enteral connectors be made of rigid materials, as described in AAMI/ANS//ISO 80369-1, Clause 4, with testing according to ASTM D747 or ASTM D790, or equivalent. Use of rigid or semi-rigid materials will reduce the likelihood of forced fits between flexible connectors that are not intended to connect with each other."
In this respect, the Cedic ENFit Transition Connectors are made of the appropriate rigid or semi-rigid materials.
B. Mechanical testing of enteral connectors to assess incompatibility
"FDA recommends mechanical force testing of enteral connectors following AAMI/ANSI/ISO 80369-1. Clause 5.8, Annex B methods, or an equivalent alternative, to demonstrate that enteral connectors are non-interconnectable with connectors from other health care applications."
Bench tests have been carried out on samples of the Cedic ENFit Transition Connectors for Enteral Applications. The tests carried out include:
- Enteral connector misconnection assessment
- Human factors .
- Fluid leakage ●
- Stress cracking
- . Resistance to separation from axial load
- Resistance to separation from unscrewing ●
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Image /page/8/Picture/0 description: The image features the word "Cedic" in a stylized, cursive font. The word is white and has a slight shadow effect, giving it a three-dimensional appearance. Above the "ic" in "Cedic" is a small, stylized "e" symbol, also in white. The background is a gradient of teal, with the lighter shade at the top and a darker shade at the bottom.
- Resistance to overriding ●
- . Disconnection by unscrewing
C. Enteral connector risk assessment
"When an applicant submits a new 510(k) application, they should provide a risk assessment to demonstrate they have effectively mitigated the risk of misconnection with their new product. There should be objective evidence that risks have been reduced to acceptable levels according to ISO 14971:2007 or equivalent. For example, the applicant may provide evidence of selection of appropriate material (Section VI.A, above) and quantitative mechanical testing data to demonstrate that the proposed enteral connector has a reduced risk of forming stable attachments to connectors routing into non-enteral devices (Section VI.B, above)."
In this respect, this 510(k) submission includes a copy of the risk analysis for the three subject transition connectors.
Predicate devices
The predicate device selected for comparison with the Cedic Enteral Distal End ENFit Transition Connector is:
| Predicate Device: | Compat Dualflo Enteral Delivery Pump Set WithSpikeright Piercing Spike and 1000ml water bag |
|---|---|
| 510(k) Sponsor: | Novartis Nutrition Corp. |
| 510(k) Number: | K080340 |
| Clearance Date: | 5 March 2008 |
| FDA Product Code: | KNT |
| Classification Name: | Gastrointestinal tube and accessories |
| Regulation No: | 876.5980 |
The predicate device selected for comparison with the Cedic Enteral ENFit Transition Connector for Medication Port is:
| Predicate Device: | Corflo Anti-IV Enteral Feeding Extension Set,Models 20-1006AIV-LB and 20-1030AIV-LB |
|---|---|
| 510(k) Sponsor: | Corpak Medsystems |
| 510(k) Number: | K083786 |
| Clearance Date: | 20 February 2009 |
| FDA Product Code: | FPD |
| Classification Name: | Tube, Feeding |
| Regulation No: | 876.5980 |
The predicate device selected for comparison with the Cedic Enteral Funnel ENFit Transition Connector is:
| Predicate Device: | Corflo Anti IV Enteral Feeding Tube |
|---|---|
| 510(k) Sponsor: | Corpak Medsystems |
| 510(k) Number: | K083210 |
| Clearance Date: | 29 December 2008 |
| FDA Product Code: | FPD |
| Classification Name: | Tube, Feeding |
| Regulation No: | 876.5980 |
The Subject Devices and the end connectors of the Predicate Devices both share many identical or similar properties and features, and none of the differences have any significant effect on safety or effectiveness of the Subject Devices.
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Image /page/9/Picture/0 description: The image shows the word "Cedic" in a stylized, cursive font. The word is white and has a slight shadow effect, giving it a three-dimensional appearance. Above the "e" in "Cedic" is a small, circular design that resembles the at symbol (@).
A fourth predicate device is included with this submission to demonstrate substantial equivalence with a further Cedic interconnecting connector, this being:
| Predicate Device: | Enteral Feeding Spike Adaptor |
|---|---|
| 510(k) Sponsor: | Cedic |
| 510(k) Number: | K072652 |
| Clearance Date: | 18 January 2008 |
| FDA Product Code: | KNT |
| Classification Name: | Gastrointestinal tube and accessories |
| Regulation No: | 876.5980 |
The subject devices share many aspects with this predicate device, including materials, manufacturing processes and methods, packaging components and processes, and biocompatibility data.
Conclusion:
Based on the information contained within this submission, it is concluded that the Cedic ENFit Transition Connectors for Enteral Applications are substantially equivalent to the identified predicate devices already in interstate commerce within the USA.
§ 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.