(221 days)
Wealy ENFit® Disposable 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.
The proposed device is a disposable enteral feeding syringe provided in a variety of sizes from 1ml~100ml. This device incorporates a female ENFit® connector for connection to an enteral access device with male ENFit® connector. The proposed 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 three years.
The provided document is a 510(k) summary for the ENFit® Disposable Enteral Syringe. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with specific acceptance criteria and detailed performance of an AI-powered diagnostic device. Therefore, many of the requested categories (expert ground truth, MRMC study, training set details) are not applicable as this is a medical device for fluid delivery, not an AI diagnostic.
However, I can extract the relevant information regarding acceptance criteria and performance based on the non-clinical tests described.
Here's a breakdown of the information that can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
The document lists various tests based on international standards (ISO, ASTM, USP). The reported performance is generally stated as "The testing demonstrates the proposed devices conform to the requirements" or "Conforms to the requirement of [standard]". Specific quantitative acceptance criteria are given by referencing clauses within these standards, implying that the device met those quantitative values.
| Acceptance Criteria Category (Referenced Standard/Clause) | Reported Device Performance |
|---|---|
| ISO 80369-3:2016 (Connectors for enteral applications) & ISO 80369-20:2015 (Common test methods): | The testing demonstrates the proposed devices conform to the requirements of ISO80369-3:2016. |
| Fluid Leakage (Annex B) | Conforms |
| Sub-atmospheric pressure Air Leakage (Annex D) | Conforms |
| Stress Cracking (Annex E) | Conforms |
| Resistance to separation from axial load (Annex F) | Conforms |
| Resistance to separation from unscrewing (Annex G) | Conforms |
| Resistance to overriding (Annex H) | Conforms |
| Disconnection by unscrewing (Annex I) | Conforms |
| ISO 7886-1:2017 (Sterile hypodermic syringe for single use): | The testing demonstrates the proposed devices conform to the requirements of ISO 7886-1:2017. |
| Appearance (Clause 5) | Conforms |
| Overall Length of Scale to Nominal Capacity Line (Clause 9.3) | Conforms |
| Push-button Distance (Clause 11) | Conforms |
| Force to Operate the Plunger (Clause 13.3) | Conforms |
| Freedom from air and liquid leakage past piston (Clause 13.2) | Conforms |
| Limits for Acidity or Alkalinity (Clause 6.2) | Conforms |
| Limits for Extractable Metals (Clause 6.3) | Conforms |
| Tolerance on graduated capacity (Clause 8) | Conforms |
| Dead Space (Clause 13.1) | Conforms |
| Lubricant (Clause 7) | Conforms |
| Cleanliness (Clause 5) | Conforms |
| Graduated Scale (Clause 9) | Conforms (Implied, listed under ISO 7886-1:2017 tests) |
| Barrel (Clause 11) | Conforms (Implied, listed under ISO 7886-1:2017 tests) |
| Piston/Plunger Assembly (Clause 13) | Conforms (Implied, listed under ISO 7886-1:2017 tests) |
| Biocompatibility Standards (ISO 10993 series): | Conforms to the requirement of ISO 10993 series Standards. No Cytotoxicity, No Irritation to Skin, No significant evidence of sensitization. Biocompatibility testing has demonstrated the biological safety. |
| ISO 10993-5:2009 (Vitro Cytotoxicity) | Conforms |
| ISO 10993-10:2010 (Irritation and skin sensitization) | Conforms |
| ISO 10993-7:2008 (Ethylene oxide sterilization residuals) | Conforms |
| ISO 10993-11:2017 (Systemic toxicity) | Conforms |
| Other Tests: | |
| ASTM F 88/F88M-09 (Seal strength of flexible barrier materials) | Conforms |
| USP38-NF33 <85> (Bacterial Endotoxins Limit) | Conforms |
| Product performance after Real-time Aging test | Evaluated properties after aging in support of labeling. |
| Package Integrity after Accelerated Aging test | Evaluated properties after aging in support of labeling. |
| Sterilization (Ethylene Oxide Gas) | Achieves SAL of 10^-6^ (for 3-year shelf life) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for each specific test in the non-clinical performance testing. It also does not specify the country of origin of the data (beyond the manufacturer being in China) or whether it was retrospective or prospective, as these are non-clinical hardware tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is an enteral syringe for fluid delivery, not a diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a diagnostic device involving expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is not an AI diagnostic or image analysis tool, so an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm or AI.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For a medical device like a syringe, "ground truth" is established by adherence to recognized international performance standards (ISO, ASTM, USP). For example, the "ground truth" for fluid leakage would be the acceptable limits defined in ISO 80369-3, and the device passing means it met those objective, standardized measures. For biocompatibility, the ground truth is defined by the toxicological profiles and testing methods in the ISO 10993 series.
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
June 28, 2021
Shantou Wealy Medical Instrument Co., Ltd. % Eva Li Consultant Shanghai Sungo Management Consulting Company Limited Room 1309, Dongfang Building, 1500#Century Ave Shanghai, Shanghai 200122 CHINA
Re: K203410
Trade/Device Name: ENFit Disposable Enteral Syringe Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: PNR Dated: May 27, 2021 Received: May 27, 2021
Dear Eva Li:
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
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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) for devices or postmarketing safety reporting (21 CFR 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 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,
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
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Indications for Use
510(k) Number (if known) K203410
Device Name
ENFit® Disposable Enteral Syringe (Model:WE1mlLD, WE2.5mlLD, WE5mlLD, WE10ml, WE30ml, WE30ml, WE100ml, WE100ml )
Indications for Use (Describe)
Wealy ENFit® Disposable 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.
| 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) |
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Shantou Wealy Medical Instrument Co., Ltd. North Jinhuan Road(near Qishan mid-school), 515064 Shantou, China
K203410 Page 1 Of 5
510(K) Summary
A. Applicant
Shantou Wealy Medical Instrument Co., Ltd. Address: North Jinhuan Road (near of Qishan Mid-school) 515064 Shantou, China Contact Person: Yang Songling Tel: +8615816758600 Fax: 0086-754-82121654
Date Prepared: June 27, 2021
Submission Correspondent Primary contact: Ms. Eva Li Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: eatereva@hotmail.com Secondary contact: Mr. Raymond Luo Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
B. Device
Trade Name: ENFit® Disposable Enteral Syringe Common Name: Enteral feeding Syringe with ENFit Connector Model: WE1mlLD, WE2.5mlLD, WE5mlLD, WE10ml, WE20ml, WE30ml, WE60ml, WE100ml
Regulatory Information Classification Name: Gastrointestinal tube and accessories Regulatory Class: 2 Product code: PNR Regulation Number: 876.5980 Device Panel: Gastroenterology/Urology
C. Predicate device: K161979 ENFit Enteral Syringe Jiangyin Caina Technology Co, Ltd.
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Shantou Wealy Medical Instrument Co., Ltd.
North Jinhuan Road(near Qishan mid-school), 515064 Shantou, China D. Indications for Use:
Wealy ENFit® Disposable 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 clinicians, in all age groups.
E. Device Description:
The proposed device is a disposable enteral feeding syringe provided in a variety of sizes from 1ml~100ml. This device incorporates a female ENFit® connector for connection to an enteral access device with male ENFit® connector. The proposed 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 three years.
F. Comparison with predicate device
Table 1 General Comparison
| Device | Proposed Device | Predicate Device | Comparison |
|---|---|---|---|
| Manufacturer | Shantou Wealy MedicalInstrument Co., Ltd. | Jiangyin Caina Technology Co,Ltd. | -- |
| 510(K)number | K203410 | K161979 | -- |
| Product Code | PNR | PNR | Same |
| RegulationNumber | CFR 876.5980 | CFR 876.5980 | Same |
| Indicationsfor Use | Wealy ENFit ™ Enteral Syringeis indicated for use as adispenser, a measuringdevice, and a fluid transferdevice. It is used to deliverfluids into the gastrointestinalsystem of a patient who isphysically unable to eat andswallow. The enteral syringesare intended to be used inclinical or home care settingby users ranging fromlaypersons (under thesupervision of a clinician) toclinicians, in all age groups. | The proposed device isindicated for use as adispenser, a measuringdevice, and a fluid transferdevice. It is used to deliverfluids into the gastrointestinalsystem of a patient who isphysically unable to eat andswallow. The enteral syringesare intended to be used inclinical or home care settingby users ranging fromlaypersons (under thesupervision of a clinician) toclinicians, in all age groups. | Same |
| Configuration | Barrel with ENFit connectorPurple Plunger | Barrel with ENFit connectorPurple Plunger | Similar* |
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| North Jinhuan Road(near Qishan mid-school), 515064 Shantou, China | |||||
|---|---|---|---|---|---|
| Piston | PistonTip cap | ||||
| Size | Low dose tipENFitTM syringe | 1ml,2.5ml,5ml | Low dosetip ENFitTM syringe | 1ml,3ml | Similar* |
| Standard ENFitTMsyringe | 10ml-100ml | StandardENFitTMsyringe | 5ml-60ml | ||
| Sterile | Yes | Yes | Same | ||
| Single use | Yes | Yes | Same | ||
| Biocompatibility | Conforms to the requirementof ISO10993 series StandardsNo CytoxicityNo Irritation to SkinNo significant evidence ofsensitization | Conforms to the requirementof ISO10993 series StandardsNo CytoxicityNo Irritation to SkinNo significant evidence ofsensitization | Same |
Shantou Wealy Medical Instrument Co., Ltd. North Jinhuan Road(near Qishan mid-school), 515064 Shantou, China
*Similar discussion
The proposed device don't configure the tip cap, it will not affect the safety and effectiveness of the proposed device.
The size of the proposed device of the low dose tip syringe or standard syringe is similar, all the size of the proposed are pass the acceptance criteria of the related performance standard requirements, so it will not affect the safety and effectiveness of the proposed device.
G. Summary of Non-Clinical Performance Testing
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:
- A ISO 80369-3:2016, Small-bore connectors for liquids and gases in healthcare application-Part3: Connectors for enteral applications;
- A 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;
- A ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity
-
ASTM F 88/F88M-09, Standard test method for seal strength of flexible barrier materials;
- A USP38-NF33 <85> Bacterial Endotoxins Limit.
- A ISO 7886-1:2017 Sterile hypodermic syringe for single use-Part 1: Syringe for manual
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Shantou Wealy Medical Instrument Co., Ltd.
North Jinhuan Road(near Qishan mid-school), 515064 Shantou, China use
Biocompatibility testing has demonstrated the biological safety of the proposed devices which may indirectly contact the patients.
Product performance after Real-time 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 80369-20:2015 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 ISO80369-3:2016.
| Individual test Defined in ISO 80369-3:2016 | Test Method Definedin ISO 80369-20:2015 |
|---|---|
| Fluid Leakage | Annex B |
| Sub-atmospheric pressure Air Leakage | Annex D |
| Stress Cracking | Annex E |
| Resistance to separation from axial load | Annex F |
| Resistance to separation from unscrewing | Annex G |
| Resistance to overriding | Annex H |
| Disconnection by unscrewing | Annex I |
Table2: Testing Item according ISO 80369-3:2016
Syringe testing performed on the proposed device included the items listed below, in accordance with ISO 7886-1:2017 Sterile hypodermic syringes for single use-Part 1: Syringe for manual use, using the test methods provided in ISO 7886-1:2017. The testing demonstrates the proposed devices conform to the requirements of ISO 7886-1:2017. Table3: Testing Item according ISO 7886-1:2017
| Individual test Defined in ISO 7886-1:2017 | Requirement Defined in ISO 7886-1:2017 |
|---|---|
| Appearance | Clause 5 |
| Overall Length of Scale to Norminal Capacity Line | Clause 9.3 |
| Push-button Distance | Clause 11 |
| Force to Operate the Plunger | Clause 13.3 |
| Freedom from air and liquid leakage past piston | Clause 13.2 |
| Limits for Acidity or Alkalinity | Clause 6.2 |
| Limits for Extractable Metals | Clause 6.3 |
| Tolerance on graduated capacity | Clause 8 |
| Dead Space | Clause 13.1 |
| Lubricant | Clause 7 |
| Cleanliness | Clause 5 |
| Graduated Scale | Clause 9 |
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| Shantou Wealy Medical Instrument Co., Ltd. | |
|---|---|
| North Jinhuan Road(near Qishan mid-school), 515064 Shantou, China |
| Barrel | Clause 11 |
|---|---|
| Piston/Plunger Assembly | Clause 13 |
H. Summary of Clinical Performance Test
No clinical study is included in this submission.
I. Conclusion
Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device, ENFit Enteral Syringe cleared under K161979.
§ 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.