(112 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties of a connector, with no mention of AI/ML algorithms or data processing.
No
Explanation: The device is an adaptor for connecting enteral feeding sets and tubes; it does not directly treat or diagnose a medical condition. It facilitates the delivery of nutrition, but is not therapeutic itself.
No
Explanation: The device is an adaptor for connecting enteral feeding sets and tubes. Its purpose is to facilitate the connection for feeding, not to diagnose a medical condition.
No
The device description clearly describes a physical adaptor made of materials and tested for mechanical properties, indicating it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to connect different types of enteral feeding sets and tubes. This is a mechanical function for delivering substances into the body, not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description focuses on the physical design of the connector and its compatibility with different feeding systems. It does not mention any reagents, calibrators, controls, or other components typically associated with IVD devices.
- Performance Studies: The performance studies described are related to the mechanical integrity and functionality of the connector (leakage, strength, compatibility, flow rate), not the analytical or clinical performance of an IVD test.
- Lack of IVD-Specific Information: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information.
The device is clearly intended for use in enteral feeding, which is a medical procedure for delivering nutrition and medication directly into the gastrointestinal tract. This falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The ENFit Adaptor is intended for connecting an enteral giving set with an ENFit connector to an enteral catheter with funnel.
Product codes (comma separated list FDA assigned to the subject device)
PIO
Device Description
To facilitate the interconnection between newly-released feeding sets, which are equipped with female ENFit connectors, and the funnel feeding ports of previously-designed enteral feeding tubes, the proposed device is designed with the mating component of an ENFit female connector, designed and tested in accordance with ISO 80369-3 and ISO 80369-20, at one of its ends, and the mating component of a non-ISO 80369-1 compliant funnel feeding port, a stepped tip connector, at its other end. It can prevent an interruption or delay in patient care by allowing fitment of enteral feeding sets with ISO 80369-3 compliant ENFit female connectors to existing enteral feeding tubes with non-ISO 80369-1 compliant end connectors, referred to as "funnel feeding ports" which are still available for use in healthcare setting.
The proposed device is sterile or non-sterile device is sterilized by ethylene oxide to achieve a SAL 10- and supplied in sterility maintenance package which maintain the sterility of the device during the shelf life 5 years.
No DEHP, BPA and Natural Rubber Latex are added in the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare professionals or lay users and patients after proper training. Healthcare or home settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 80369-3:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications [Including AMENDMENT 1 (2019)].
- ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods.
The tests carried out include: Fluid Leakage, Stress Cracking, Resistance to Separation from Axial Load, Resistance to Separation from Unscrewing, Resistance to Overriding, Disconnection by Unscrewing, Connector Incompatibility Test, Materials Used for Small-bore Connectors, Dimensional analysis, Compatibility and Usability Test.
In addition, the performance test of stepped tip connector of ENFit Adaptor has been carried out according to Clause V.B of Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications - Guidance for Industry and Food and Drug Administration Staff .Document issued on February 11, 2015 and ISO 20695:2020 Enteral feeding systems - Design and testing.
The tests carried out include: Mechanical testing of enteral connectors to assess incompatibility, Tensile properties, Liquid leakage, Flow Rate.
Risk assessment: This 510(k) submission includes a copy of the risk assessment for the ENFit Adaptor to demonstrate that risks have been reduced to acceptable levels according to ISO 14971:2019.
Biocompatibility: In accordance with ISO 10993-1, the adaptor is classified as: Surface device, Mucosal membrane, Limited contact (≤ 24 h). The following endpoints were evaluated:
- ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
- ISO 10993-23:2021 Biological evaluation of medical devices Part 23: Tests for irritation.
- ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization.
Sterilization, Shipping and Shelf-Life: The subject device has a 5 year shelf life.
- ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009), AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019)]
- ASTM F1929-15 Standard test method for detecting seal leaks in porous medical packaging by dye penetration.
- ASTM F88/F88M-21 Standard Test 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 Bacterial Endotoxins Test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font below that.
January 18, 2024
Jiangsu Caina Medical Co., Ltd. Camel Zhou Management Representative No.23, Huanxi Road, Zhutang Town Jiangyin, Jiangsu 214415 China
Re: K233190
Trade/Device Name: ENFit Adaptor Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal Tube And Accessories Regulatory Class: Class II Product Code: PIO Dated: December 6, 2023 Received: December 14, 2023
Dear Camel Zhou:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Sivakami Venkatachalam -S
for
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K233190
Device Name ENFit Adaptor
Indications for Use (Describe)
The ENFit Adaptor is intended for connecting an enteral giving set with an ENFit connector to an enteral catheter with funnel.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/1 description: The image shows the word "CAINA" in blue font with a green triangle in the middle of the "A". Below the word is "www.cainamed.com" in a smaller font. To the right of the word is "K233190" and "Page 1 of 6".
Tab 6 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K233190
-
- Date of Preparation: May 15, 2023
-
- 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
-
- Designated Submission Correspondent
Mr. Camel Zhou (Primary Contact Person) Email: camel.zhou@cainamed.com Ms. Tracy Gong (Alternative Contact Person) Email: tracy.gong(@cainamed.com Tel: +86-510-86866666-8027 Fax: +86-510-86866666-8009
- Designated Submission Correspondent
-
- Identification of Proposed Device
Trade Name: ENFit Adaptor
- Identification of Proposed Device
Regulatory Information Regulation Name: Gastrointestinal tube and accessories Device Class: II Product Code: PIO Regulation Number: 21 CFR 876.5980 Review Panel: Gastroenterology/Urology
4
Indications for Use Statement:
The ENFit Adaptor is intended for connecting an enteral giving set with an ENFit connector to an enteral catheter with funnel.
- ર. Device Description
To facilitate the interconnection between newly-released feeding sets, which are equipped with female ENFit connectors, and the funnel feeding ports of previously-designed enteral feeding tubes, the proposed device is designed with the mating component of an ENFit female connector, designed and tested in accordance with ISO 80369-3 and ISO 80369-20, at one of its ends, and the mating component of a non-ISO 80369-1 compliant funnel feeding port, a stepped tip connector, at its other end. It can prevent an interruption or delay in patient care by allowing fitment of enteral feeding sets with ISO 80369-3 compliant ENFit female connectors to existing enteral feeding tubes with non-ISO 80369-1 compliant end connectors, referred to as "funnel feeding ports" which are still available for use in healthcare setting.
The proposed device is sterile or non-sterile device is sterilized by ethylene oxide to achieve a SAL 10- and supplied in sterility maintenance package which maintain the sterility of the device during the shelf life 5 years.
No DEHP, BPA and Natural Rubber Latex are added in the device.
-
- Identification of Predicate Device
Predicate Device 510(k) Number: K140581 Product Name: Cedic Enteral Distal End ENFit Transition Connector
- Identification of Predicate Device
-
- Clinical Test Conclusion
Not applicable.
- Clinical Test Conclusion
-
- Substantially Equivalent (SE) Comparison
| ITEM | Proposed Device | Predicate Device
K140581 | Comment |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Product code | PIO | PIO | Same |
| Regulation No. | 21 CFR 876.5980 | 21 CFR 876.5980 | Same |
| Regulation
Name | Gastrointestinal tube and
accessories | Gastrointestinal tube and
accessories | Same |
| Class | II | II | Same |
| | The ENFit adaptor is intended
for connecting an enteral giving
set with an ENFit connector to
an enteral catheter with funnel. | 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. | Same |
| Indications for
use | | | |
| | Only one configuration: | Three configurations: | |
| Configuration | ENFit Adaptor: designed to
connect an enteral giving set
equipped with an ENFit female
connector to an enteral catheter
equipped with soft funnel port. | 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.
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.
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. | Same
The only one
configuration of
the proposed
device is included
in the three
configurations of
predicate devices |
| | | | |
| Rx vs. OTC | Rx | Rx | Same |
| Material | ABS PA-757;
LDPE 2420H;
Purple color additive. | ABS HF 380;
LDPE (Riblene MM20);
soft PVC (Nakan FMA919N);
Remafin Violet PE43076356-ZT
(2%). | Different
Comment 1 |
| Expiration Date | 5 years | 3years | Different |
| | | | Comment 2 |
| Sterilization | Sterile or non-sterile | Non-sterile | Different |
| | | | Comment 3 |
| Single use | Yes | Yes | same |
| Condition of | Healthcare or home settings | Healthcare or home settings | same |
| Use(Environment) | | | |
| User population | Healthcare professionals or lay users and patients after proper training | Healthcare professionals or lay users and patients after proper training | same |
| Operating Principle | 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 | 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 | same |
Table 1 Comparison of Technology Characteristics with K140581
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Comment 1
The patient contact materials for the proposed device are different from predicate device. 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 proposed device is external communicating device of surface device, mucosal membrane and limited contact. The Cytotoxicity test, Sensitization test, Intracutaneous reactivity test have been performed for proposed device. Therefore, this material difference does not affect substantially equivalence on safety and effectiveness.
Comment 2
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 ISO80369-3 and ISO 80369-20. 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 ISO 11607 and ISTA 3A. Therefore, this expiration date difference does not affect substantially equivalence on safety and effectiveness.
Comment 3
Compared with the predicate device, the proposed device has added the provision of sterile method is EO, and the SAL level is validated at 106. The performance after sterilization is tested according to ISO 80369-3 and ISO 80369-20, and the residual level of EO/ECH meet the requirements of ISO 10993-7:2008/Amd.1:2019. Therefore, this difference does not affect substantially equivalence on safety and effectiveness.
9. Non-Clinical Test
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:
7
Performance
- A ISO 80369-3:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications [Including AMENDMENT 1 (2019)].
-
ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods.
The tests carried out include:
- Fluid Leakage
- Stress Cracking
- Resistance to Separation from Axial Load
- Resistance to Separation from Unscrewing
- Resistance to Overriding
- Disconnection by Unscrewing
- Connector Incompatibility Test
- Materials Used for Small-bore Connectors
- Dimensional analysis ●
- Compatibility and Usability Test ●
In addition, the performance test of stepped tip connector of ENFit Adaptor has been carried out according to Clause V.B of Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications - Guidance for Industry and Food and Drug Administration Staff .Document issued on February 11, 2015 and ISO 20695:2020 Enteral feeding systems - Design and testing.
The tests carried out include:
- Mechanical testing of enteral connectors to assess incompatibility
- Tensile properties
- Liquid leakage
- Flow Rate
Risk assessment
This 510(k) submission includes a copy of the risk assessment for the ENFit Adaptor to demonstrate that risks have been reduced to acceptable levels according to ISO 14971:2019.
Biocompatibility
In accordance with ISO 10993-1, the adaptor is classified as: Surface device, Mucosal membrane, Limited contact (≤ 24 h). The following endpoints were evaluated:
-
ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
- ISO 10993-23:2021 Biological evaluation of medical devices Part 23: Tests for irritation. >
-
ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization.
Sterilization, Shipping and Shelf-Life
The subject device has a 5 year shelf life
- A ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009), AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019)]
-
ASTM F1929-15 Standard test method for detecting seal leaks in porous medical packaging by dye
8
penetration.
-
ASTM F88/F88M-21 Standard Test Method for Seal Strength of Flexible Barrier Materials.
- A ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection.
- A USP Bacterial Endotoxins Test.
-
- Substantially Equivalent (SE) Conclusion
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The ENFit Adaptor is substantially equivalent to the Cedic Enteral Distal End ENFit Transition Connector with respect to the indications for use, target population, treatment method, and technological characteristics.