(247 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a syringe, with no mention of AI or ML capabilities.
No.
The device is described as a dispenser, measuring device, and fluid transfer device used to deliver fluids. It is not described as treating, preventing, or mitigating a disease or condition.
No.
The device is described as a dispenser, measuring device, and fluid transfer device, used to deliver fluids for feeding, not to diagnose a medical condition.
No
The device description clearly states it is a disposable enteral feeding syringe, which is a physical hardware device. The performance studies also focus on physical properties and testing of the syringe hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used to "deliver fluids into the gastrointestinal system of a patient". This is a direct interaction with the patient's body for therapeutic or supportive purposes.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro).
- Device Description: The description of the enteral feeding syringe and its connection to an enteral access device further confirms its use for delivering substances into the body.
The device described is a medical device used for patient care, specifically for enteral feeding, which is a form of delivering nutrition or medication directly into the digestive system. This falls under the category of medical devices used for treatment or support, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The proposed device is indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral syringes are intended to be used in clinical or home care setting by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups.
Product codes
PNR
Device Description
The proposed device is a disposable enteral feeding syringe provided in a variety of sizes from 1ml~60ml. This device incorporates a female ENFit connection to an enteral access device with male ENFit connector.
The propsoed syringe is sterilized by Ethylene Oxide Gas to achieve a SAL of 10 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal system
Indicated Patient Age Range
all age groups
Intended User / Care Setting
clinical or home care setting by users ranging from laypersons (under the supervision of a clinician) to clinicians
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:
- AAMI/CN3 (PS):2014, Small-bore connectors for liquids and gases in healthcare application-Part 3: Connectors for enteral applications;
- ISO 80369-3:2016, Small-bore connectors for liquids and gases in healthcare application-Part 3: Connectors for enteral applications;
- ISO 80369-20:2015, Small-bore connectors for liquids and gases in healthcare application-Part 20: Common test methods:
- ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro Cytotoxicity;
- ISO 10993-10:2010, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization;
- ISO 10993-7:2008, Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals;
- ASTM F 88/F88M-09, Standard test method for seal strength of flexible barrier materials;
- ASTM F1140/F1140-13, Standard test methods for internal pressurization failure resistance of unrestrained packages
- USP37-NF32 Bacterial Endotoxins Limit.
- ISO 7886-1:1993 Sterile hypodermic syringe for syring use-Part 1: Syringe for manual use
Biocompatibility testing has demonstrated the biological safety of the proposed devices which may indirectly contact the patients.
Product performance after Accelerated Aging test and Package Integrity after Accelerated Aging test evaluated the properties of the enteral feeding syringes after accelerated aging in support of the labeling.
Connector testing performed on the proposed device included the items listed below, in accordance with ISO 80369-3:2016, Small-bore connectors for liquids and gases in healthcare applications -Part 3: Connectors for enteral applications, using the test methods provided in ISO 80369-20, Small-bore connectors for liquids and gases in healthcare applications – Part 20: Common test methods. The testing demonstrates the proposed devices conform to the requirements of ISO 80369-3:2016.
- Fluid Leakage
- Stress Cracking
- Resistance to separation from axial load
- Resistance to separation from unscrewing
- Resistance to overriding
- Disconnection by unscrewing
Syringe testing performed on the proposed device included the items listed below, in accordance with ISO 7886-1:1993, Sterile hypodermic syringe for syring use-Part 1: Syringe for manual use, using the test methods provided in ISO 7886-1:1993. The testing demonstrates the proposed devices conform to the requirements of ISO 7886-1:1993.
- Cleanliness
- Limits for acidity or alkalinity
- Limits for extractable metals
- Lubricant
- Tolerance on graduated capacity
- Graduated scale
- Barrel
- Piston/plunger assembly
- Dead space
- Freedom from air and liquid leakage past piston
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 5, 2017
Jiangsu Caina Medical Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 China
Re: K161979 Trade/Device Name: ENFit Enteral Syringe Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tubes and Accessories Regulatory Class: II Product Code: PNR Dated: February 15, 2017 Received: February 21, 2017
Dear Diana Hong:
This letter corrects our substantially equivalent letter of March 22, 2017.
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.
1
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 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" (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.
Benjamin R. Fisher -S
Beniamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name ENFit Enteral Syringe
Indications for Use (Describe)
The proposed device is indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral syringes are intended to be used in clinical or home care setting by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups.
| 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
Tab #7 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: ________
-
- Date of Preparation: 03/17/2017
- Sponsor Identification 2.
Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Road, Zhutang Town, Jiangyin, Jiangsu, 214425, China
Establishment Registration Number: 3005670221
Contact Person: Jun Lu Position: General Manager Tel: +86-510-86205183 Fax: +86-510-86215183 Email: jun.lu@cainamedical.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: ENFit Enteral syringe Common Name: Enteral Feeding Syringe with ENFit Connector Size: 1ml, 3ml, 5ml, 6ml, 10ml, 12ml, 20ml, 30ml, 35ml, 50ml, 60ml
Regulatory Information
Classification Name: Gastrointestinal tube and accessories; Classification: II; Product Code: PNR Regulation Number: CFR 876.5980; Review Panel: Gastroenterology/Urology;
Indications for Use:
ENFit Enteral Syringe is indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral syringes are intended to be used in clinical or home care setting by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups.
Device Description
The proposed device is a disposable enteral feeding syringe provided in a variety of sizes from 1ml~60ml. This device incorporates a female ENFit connection to an enteral access device with male ENFit connector.
The propsoed syringe is sterilized by Ethylene Oxide Gas to achieve a SAL of 10 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.
5. Identification of Predicate Device
Predicate device 510(k) Number: K161039 Manufacturer: NeoMed, Inc. Product Name: NeoConnector Oral/Enternal Feeding Syringes with ENFit Connector (12ml to 100ml) NeoConnector Low Dose Tip Oral/Enternal Feeding Syringes with ENFit Connector (0.5ml to 6ml)
Non-Clinical Test Conclusion 6.
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:
5
-
AAMI/CN3 (PS):2014, Small-bore connectors for liquids and gases in healthcare application-Part 3: Connectors for enteral applications;
-
ISO 80369-3:2016, Small-bore connectors for liquids and gases in healthcare application-Part 3: Connectors for enteral applications;
-
ISO 80369-20:2015, Small-bore connectors for liquids and gases in healthcare application-Part 20: Common test methods:
-
ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro Cytotoxicity;
-
ISO 10993-10:2010, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization;
-
ISO 10993-7:2008, Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals;
-
ASTM F 88/F88M-09, Standard test method for seal strength of flexible barrier materials;
-
ASTM F1140/F1140-13, Standard test methods for internal pressurization failure resistance of unrestrained packages
-
USP37-NF32 Bacterial Endotoxins Limit.
-
ISO 7886-1:1993 Sterile hypodermic syringe for syring use-Part 1: Syringe for manual use
Biocompatibility testing has demonstrated the biological safety of the proposed devices which may indirectly contact the patients.
Product performance after Accelerated Aging test and Package Integrity after Accelerated Aging test evaluated the properties of the enteral feeding syringes afteraccelerated aging in support of the labeling.
Connector testing performed on the proposed device included the items listed below, in accordance with ISO 80369-3:2016, Small-bore connectors for liquids and gases in healthcare applications -Part 3: Connectors for enteral applications, using the test methods provided in ISO 80369-20, Small-bore connectors for liquids and gases in healthcare applications – Part 20: Common test methods. The testing demonstrates the proposed devices conform to the requirements of ISO 80369-3:2016.
| Individual test Defined in ISO 80369-3 | Requirement Defined in
AAMI/CN3 (PS):2014 | Test Method Defined
in ISO 80369-20 |
|------------------------------------------|----------------------------------------------|----------------------------------------|
| Fluid Leakage | Clause 6.2 | Annex C |
| Stress Cracking | Clause 6.3 | Annex E |
| Resistance to separation from axial load | Clause 6.4 | Annex F |
| Resistance to separation from unscrewing | Clause 6.5 | Annex G |
| Resistance to overriding | Clause 6.6 | Annex H |
| Disconnection by unscrewing | Clause 6.7 | Annex I |
6
Syringe testing performed on the proposed device included the items listed below, in accordance with ISO 7886-1:1993, Sterile hypodermic syringe for syring use-Part 1: Syringe for manual use, using the test methods provided in ISO 7886-1:1993. The testing demonstrates the proposed devices conform to the requirements of ISO 7886-1:1993.
| Individual test Defined in ISO 7886-1:1993 | Requirement Defined in ISO 7886-1:1993 |
|---|---|
| Cleanliness | Clause 5 |
| Limits for acidity or alkalinity | Clause 6 |
| Limits for extractable metals | Clause 7 |
| Lubricant | Clause 8 |
| Tolerance on graduated capacity | Clause 9 |
| Graduated scale | Clause 10 |
| Barrel | Clause 11 |
| Piston/plunger assembly | Clause 12 |
| Dead space | Clause 14.1 |
| Freedom from air and liquid leakage past piston | Clause 14.2 |
- Substantially Equivalent (SE) Comparison 7.
| Table 1 Comparison of Technology Characteristics | ||
|---|---|---|
| Item | Proposed Device | Predicate Device |
| Product Code | PNR | K161039 |
| PNR | ||
| Regulation | ||
| Number | CFR 876.5980; | CFR 876.5980; |
| Intended Use | The proposed device is indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral syringes are intended to be used in clinical or home care setting by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups. | 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 or home care setting by users ranging from clinicians to laypersons (under the supervision of a clinician) in all age groups. |
| Configuration | Barrel with ENFit connector | Barrel with ENFit connector |
| Purple Plunger | Purple Plunger | |
| Piston | Piston | |
| Tip cap | Tip cap | |
| Size | Low dose tip ENFit syringe 1ml, 3ml | Low dose tip ENFit syringe 0.5ml-6ml |
| Standard ENFit syringe 5ml-60ml | Standard ENFit syringe 12ml-100ml | |
| Sterile | Yes | Yes |
| Single Use | Yes | Yes |
Table 1 Comparison of Technology Characteristics
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| Biocompatibility | Conforms to the requirement of ISO 10993 series Standards | Conforms to the requirement of ISO 10993 series Standards |
|---|---|---|
| No Cytoxicity | No Cytoxicity | |
| No Irritation to Skin | No Irritation to Skin | |
| No significant evidence of sensitization | No significant evidence of sensitization |
Product Comparison Summary
The proposed device and predicate device are intended for patients who require enteral nutrition due to illness or injury which prevents normal chewing and swallowing. These products are enteral syringes that have the same smalll-bore connector, similar intended use and product specification
The difference between the proposed device and predicate device is the size of the syringe; both the proposed device and the predicate device comply with the relevant international Standards. Therefore the differences on syringe size will not raise new problems on safety and effectiveness of the proposed device.
8. 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.