(129 days)
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.
Yes
The device is used to deliver nutritional formula to the gastrointestinal system, which is a therapeutic intervention for patients unable to eat and swallow.
No
Explanation: The device is an enteral feeding syringe intended to deliver nutritional formula, not to diagnose a condition or disease.
No
The device description clearly outlines a physical syringe with components like a plunger, piston, barrel, and tip, made of materials like Polypropylene and Polyisoprene rubber. It is a hardware device used to deliver fluids.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is an Enteral Pump Syringe. Its function is to deliver nutritional formula directly into the gastrointestinal system of a patient. This is a method of administering substances into the body, not analyzing samples from the body.
- Intended Use: The intended use clearly states the delivery of nutritional formula to the gastrointestinal system. There is no mention of analyzing biological samples or providing diagnostic information.
Therefore, the Enteral Pump Syringe falls under the category of a medical device used for administration, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Enteral Pump Syringe delivers nutritional formula to the gastrointestinal system of a patient who is physically unable to eat and swallow. Enteral Pump Syringe is intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to health care professionals, to administer nutritional formula. In particular, these syringes can be connected with enteral infusion pump. Enteral Pump Syringe is intended for neonatal, pediatric and adult use. Enteral Pump Syringe is single use device.
Product codes (comma separated list FDA assigned to the subject device)
PNR
Device Description
The proposed device is modified device of K190502(ENFit Oral/Enteral Syringe,cleared July 2, 2019) according to 21CFR 820.30. The change is a operation mode change from manual use to use with infusion pump.
The proposed device is a disposable enteral feeding syringe provided in a variety of sizes from 1ml to 60ml. The ENFit enteral feeding syringe consists of moveable plunger, piston, calibrated hollow barrel and tip cap(not necessary). At the distal end of the barrel is a female connector, designed according to ISO 80369-3 (often referred to as an ENFit connection). The tip is designed to mate only with enteral administration devices and is incompatible with Luer connectors. The device is used to deliver fluids into the body enterally by connected to an enteral access device with male ENFit connector. The syringes (size 6ml to 60ml) incorporate a female Standard ENFit connector; the syringes (size 1ml and 6ml) incorporate a female low dosing ENFit connector.
There are 2 types of ENFit connector ENFit syringe and central connector ENFit syringe. The sizes of the Side connector ENFit syringe range from 12ml to 60ml; and The sizes of the central connector ENFit syringe range from 1ml to 60ml. The syringes are provided with transparent or amber color barrel.
The material used of deviec are Polypropylene. Polyisoprene rubber, Polydimethysiloxane(inside surface coating of barrel ). Amber additive(for used amber color barrel only), which are also patient-contacting materials for the proposed devices. The time of contact duration is less than 24 hours. The contact level is mucosal membrane, indirect.
The proposed device is sterile or non-sterile, single use. The sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.
The proposed device intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to health care professionals. The device has no energy in itself. But the syringe works with infusion pump and extension sets.The syringe is aspirated nutritional formula liquid, connected the extension set. Then user installed it on the infusion pump, and pump fluids into a body enterally in a controlled manner for administer enteral nutrition. The accuracy of graduations for enteral syringes is +/- 4% of expelled volume.
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
neonatal, pediatric and adult use
Intended User / Care Setting
users ranging from laypersons (under the supervision of a clinician) to health care professionals, in clinical or home care 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
ISO 80369-20:2015 Small-Bore Connectors for Liquids And Gases in Healthcare Applications-Part 20: Common Test Methods;
ISO 7886-1:2017 Sterile Hypodermic Syringes for Single Use-Part 1: Syringes for Manual Use;
ISO 7886-2:2020 Sterile Hypodermic Syringes for Single Use-Part 2: Syringes for use with power-driven syringe pumps;
ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests for in 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 ISO 14971:2007 Medical Devices-Application of Risk Management to Medical Devices;
ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials;
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration:
ASTM F1886F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection.
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.
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
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September 30, 2021
Jiangsu Caina Medical Co., Ltd. Jianwei Pan Management Representative No.23 Huanxi Road, Zhutang Town Jiangyin, Jiangsu 214415 CHINA
Re: K211593
Trade/Device Name: Enteral Pump Syringe Regulation Number: 21 CFR 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: Class II Product Code: PNR Dated: August 24, 2021 Received: August 30, 2021
Dear Jianwei Pan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
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
2
Indications for Use
510(k) Number (if known) K211593
Device Name Enteral Pump Syringe
Enteral Pump Syringe delivers nutritional formula to the gastrointestinal system of a patient who is physically unable to eat and swallow.
Enteral Pump Syringe is intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to health care professionals, to administer nutritional formula. In particular, these syringes can be connected with enteral infusion pump.
Enteral Pump Syringe is intended for neonatal, pediatric and adult use.
Enteral Pump Syringe is single use device.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
| Y Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Tab 7 510(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: K211593
-
- Date of Preparation: 05/10/2021
-
- Sponsor Identification
Jiangsu Caina Medical Co., Ltd.
No.23, Huanxi Rd. Zhutang Town, 214415 Jiangyin City, Jiangsu, 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
3. Designated Submission Correspondent
Mr. Jianwei pan (Primary Contact Person) Email: jianwei.pan@cainamed.com Ms. Xinyan Ruan (Alternative Contact Person) Email: sherry.ruan@cainamed.com Tel: +86-510-86866666-8027 Fax: +86-510-86866666-8009
- Identification of Proposed Device 4.
Trade Name: Enteral Pump Syringe Common Name: Enteral Feeding Syringe with ENFit Connector Regulatory Information Classification Name: Gastrointestinal tube and accessories Classification: II; Product Code: PNR Regulation Number: 21CFR 876.5980 Review Panel: Gastroenterology/Urology; Indications for Use Statement: Enteral Pump Syringe delivers nutritional formula to the gastrointestinal system of a patient who is physically unable to eat and swallow. Enteral Pump Syringe is intended to be used in clinical or home care settings by users ranging from
4
K211593 Page 2 of 7
510(k) Summary
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laypersons (under the supervision of a clinician) to health care professionals, to administer nutritional formula. In particular, these syringes can be connected with enteral infusion pump. Enteral Pump Syringe is intended for neonatal, pediatric and adult use. Enteral Pump Syringe is single use devices.
Device Description:
The proposed device is modified device of K190502(ENFit Oral/Enteral Syringe,cleared July 2, 2019) according to 21CFR 820.30. The change is a operation mode change from manual use to use with infusion pump.
The proposed device is a disposable enteral feeding syringe provided in a variety of sizes from 1ml to 60ml. The ENFit enteral feeding syringe consists of moveable plunger, piston, calibrated hollow barrel and tip cap(not necessary). At the distal end of the barrel is a female connector, designed according to ISO 80369-3 (often referred to as an ENFit connection). The tip is designed to mate only with enteral administration devices and is incompatible with Luer connectors. The device is used to deliver fluids into the body enterally by connected to an enteral access device with male ENFit connector. The syringes (size 6ml to 60ml) incorporate a female Standard ENFit connector; the syringes (size 1ml and 6ml) incorporate a female low dosing ENFit connector.
There are 2 types of ENFit connector ENFit syringe and central connector ENFit syringe. The sizes of the Side connector ENFit syringe range from 12ml to 60ml; and The sizes of the central connector ENFit syringe range from 1ml to 60ml. The syringes are provided with transparent or amber color barrel.
The material used of deviec are Polypropylene. Polyisoprene rubber, Polydimethysiloxane(inside surface coating of barrel ). Amber additive(for used amber color barrel only), which are also patient-contacting materials for the proposed devices. The time of contact duration is less than 24 hours. The contact level is mucosal membrane, indirect.
The proposed device is sterile or non-sterile, single use. The sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.
The proposed device intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to health care professionals. The device has no energy in itself. But the syringe works with infusion pump and extension sets.The syringe is aspirated nutritional formula liquid, connected the extension set. Then user installed it on the infusion pump, and pump fluids into a body enterally in a controlled manner for administer enteral nutrition. The accuracy of graduations for enteral syringes is +/- 4% of expelled volume.
- ર. Identification of Predicate Device
5
K211593 Page 3 of 7
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510(k) Summary
Predicate Device 510(k) Number: K161141 Classification :II Product code :PNR Regulation number :21 CFR 876.5980 Registered Establishment Name: Pentaferte Italia s.r.l. Address: Loc. Nocella SP 262,I-64012 Campli (TE)-Italy Product Name: ENFit enteral pump syringes PENTA ENFit™ ENFit enteral pump syringes NUTRIFIT™
6. Non-Clinical Test Conclusion
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
ISO 80369-20:2015 Small-Bore Connectors for Liquids And Gases in Healthcare Applications-Part 20: Common Test Methods;
ISO 7886-1:2017 Sterile Hypodermic Syringes for Single Use-Part 1: Syringes for Manual Use;
ISO 7886-2:2020 Sterile Hypodermic Syringes for Single Use-Part 2: Syringes for use with power-driven syringe pumps;
ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests for in 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 ISO 14971:2007 Medical Devices-Application of Risk Management to Medical Devices;
ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials;
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration:
ASTM F1886F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
7. Clinical Test Conclusion
No clinical study is included in this submission.
6
www.cainamed.com
510(k) Summary
Substantially Equivalent (SE) Comparison 8.
| ITEM | Proposed Device | Predicate Device, K161141 | Remark |
|---|---|---|---|
| Regulation No. | 21CFR 876.5980 | 21CFR 876.5980 | Same |
| Product Code | PNR | PNR | Same |
| Class | II | II | Same |
| Indications for Use | Enteral Pump Syringes deliver | ||
| nutritional formula to the | |||
| gastrointestinal system of a patient | |||
| who is physically unable to eat and | |||
| swallow. | |||
| Enteral Pump Syringes are intended | |||
| to be used in clinical or home care | |||
| settings by users ranging from | |||
| laypersons (under the supervision of a | |||
| clinician) to health care professionals, | |||
| to administer nutritional formula. In | |||
| particular, these syringes can be | |||
| connected with enteral infusion | |||
| pump. | |||
| Enteral Pump Syringes are intended | |||
| for neonatal, pediatric and adult use. | |||
| Enteral Pump Syringes are single use | |||
| devices. | ENFit enteral pump syringes PENTA | ||
| ENFitTM and ENFit enteral pump | |||
| syringes NUTRIFITTM deliver | |||
| nutritional formula to the | |||
| gastrointestinal system of a patient | |||
| who is physically unable to eat and | |||
| swallow. ENFit enteral pump syringes | |||
| (PENTA ENFitTM and NUTRIFITTM) | |||
| are intended to be used in clinical or | |||
| home care settings by users ranging | |||
| from laypersons (under the supervision | |||
| of a clinician) to health care | |||
| professionals, to administer nutritional | |||
| formula. In particular, these syringes | |||
| can be connected with enteral infusion | |||
| pump. | |||
| ENFit enteral pump syringes (PENTA | |||
| ENFitTM and NUTRIFITTM) are | |||
| intended for neonatal, pediatric and | |||
| adult use. | |||
| ENFit enteral pump syringes are single | |||
| use devices. | Same | ||
| Environment | |||
| of Use | Clinical or home care settings | Clinical or home care settings | Same |
| Configuration | Piston; | ||
| Plunger; | |||
| Barrel with ENFit connector; | |||
| Tip cap | Piston; | ||
| Plunger; | |||
| Barrel with ENFit connector; | |||
| Tip cap | Same | ||
| Operation | |||
| Mode | Syringes can be connected with | ||
| enteral infusion pump. The user | |||
| installed it on the infusion pump, and | |||
| pump fluids into a body enterally in a | |||
| controlled manner. | These syringes can be connected with | ||
| enteral infusion pump.The user | |||
| installed it on the infusion pump, and | |||
| pump fluids into a body enterally in a | |||
| controlled manner. | Same | ||
| Pump | |||
| compatibility | Pump compatibility is demonstrated | ||
| by the in vitro bench tests on ENFit | Pump compatibility is demonstrated by | ||
| the in vitro bench tests on ENFit | Same |
| Table 1 Comparison of Technology Characteristics | ||
|---|---|---|
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K211593 Page 5 of 7
Image /page/7/Picture/1 description: The image shows the logo for CAINA. The logo is blue and green, with the word "CAINA" in large, bold letters. Below the logo is the website address "www.cainamed.com" in blue. The logo is simple and modern.
| 510(k) Summary | www.cainamed.com | ||
|---|---|---|---|
| enteral pump syringes, which show the compliance with the applicable requirements of the ISO 7886-1 and ISO 7886-2. | enteral pump syringes, which show the compliance with the applicable requirements of the ISO 7886-1 and ISO 7886-2. | ||
| Label/labeling | Conform with 21CFR Part 801 Subpart D | Conform with 21CFR Part 801 Subpart D | Same |
| Product model | Low dose tip ENFit Syringe: 1ml, 3ml, 6ml | ||
| Standard ENFit Syringe: 6ml, 12ml, 20ml, 35ml, 60ml | 10ml, 20 ml, 60 ml | Analysis 1 | |
| Product Performance | Complied with: | ||
| ISO 80369-3; | |||
| ISO 80369-20; | |||
| ISO 7886-1; | |||
| ISO 7886-2; | Complied with: | ||
| ISO 80369-3; | |||
| ISO 80369-20; | |||
| ISO 7886-1; | |||
| ISO 7886-2; | Same | ||
| Connector type | ISO80369-3, female ENFit connector, | ||
| low dose tip for 1ml/3ml/6ml syringe, | |||
| Standard tip for | |||
| 6ml/12ml/20ml/35ml/60ml syringe, | |||
| Side connector for | |||
| 12ml/20ml/35ml/60ml syringe | ISO 80369-3, female ENFit connector | Analysis 3 | |
| Patient Contact Material | Barrel:Polypropylene | ||
| Plunger:Polypropylene | |||
| Piston:Polyisoprene | |||
| Lubricant:Polydimethysiloxane | |||
| Color additives:Amber additive | Polypropylene | ||
| Ink/Colorants | |||
| Silicone oil | |||
| (Polydimethylsiloxane) | |||
| Latex Free, nontoxic synthetic rubber | Analysis 2 | ||
| Biocompatibility | Meet the applicable Biocompatibility requirements according to ISO 10993 | ||
| Cytotoxicity No Cytotoxicity | |||
| Skin Irritation No Irritation | |||
| Sensitization No Sensitization | ENFit enteral pump syringes satisfy the applicable Biocompatibility requirements according to ISO 10993 | Same | |
| Sterilization Status | Sterile and non-sterile | Sterile; No clear non sterile , but in 510(k) summary is stated that the device were carried out bioburden tests. | Same |
| Method | EO Sterilized | EO Sterilized | Same |
| SAL | 10-6 | 10-6 | Same |
| Single Use | Single Use | Single Use | Same |
Analysis 1
The proposed device is modified device of ENFit Oral/Enteral Syringe (K190502,cleared July 2, 2019). The change is a operation mode change from manual use to use with infusion pump. The proposed device have
8
510(k) Summary
more product available model than predicate device. These product models were tested according to ISO 7886-1 and ISO 7886-2. These product models were conducted to compatibility tests with the recommended infusion pumps. There is available model 0.5ml to 100ml in K143344 of the summary of predicate device. Therefore, this difference does not affect substantially equivalence on safety and effectiveness.
Analysis 2
The patient contact material for the predicate devices is difference. 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 Surface device of mucosal membrane and limited contact. The Cytotoxicity test, Sensitization test, and Irritation test have been performed for proposed device. Therefore, this difference does not affect substantially equivalence on safety and effectiveness.
Analysis 3
There are different connectors in proposed devices. There is not change with ENFit Oral/Enteral Syringe (K190502). These product models were tested according to ISO 80369-3. These product models were conducted to compatibility tests with the recommended infusion pumps. Therefore, this difference does not affect substantially equivalence on safety and effectiveness.
9
510(k) Summary
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-
- Substantially Equivalent (SE) Conclusion
Based on the comparison above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.
- Substantially Equivalent (SE) Conclusion